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NIH's All of Us Research Program is Now the Largest Integrated Genomics and Health Database in the World
WASHINGTON, July 1 -- The U.S. Department of Health and Human Services National Institutes of Health issued the following news release:
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NIH's All of Us Research Program is now the largest integrated genomics and health database in the world
Data from more than 747,000 participants is now available to scientists, powering next-generation discoveries in precision medicine.
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The National Institutes of Health (NIH) has issued the most expansive data release in the history of its All of Us Research Program, making available data from more than 747,000 participants and establishing All of ... Show Full Article WASHINGTON, July 1 -- The U.S. Department of Health and Human Services National Institutes of Health issued the following news release: * * * NIH's All of Us Research Program is now the largest integrated genomics and health database in the world Data from more than 747,000 participants is now available to scientists, powering next-generation discoveries in precision medicine. - The National Institutes of Health (NIH) has issued the most expansive data release in the history of its All of Us Research Program, making available data from more than 747,000 participants and establishing All ofUs as the world's largest integrated genomic and electronic health record (EHR) database. The latest data release includes more than 535,000 whole genome sequences linked to nearly 482,000 electronic health records, a combination of genomic depth and clinical breadth unmatched by any research program in the world.
"There's a paradox at the heart of precision medicine," said NIH Director Jay Bhattacharya, M.D., Ph.D. "To tailor treatments to individuals, you actually need very large populations to uncover the patterns that connect genetics, lifestyle, and the environment to health outcomes. That is exactly what All of Us provides: research at unprecedented scale."
The new data issuance represents growth of more than 114,000 participants since the previous data version, bringing the program's total enrolled-participant count to over 883,000. The dataset now encompasses more than 1.3 billion genetic variants, 553,000 genotyping arrays, 96,000 structural variant records, and 600,000 physical measurements, alongside 747,000 survey responses capturing social circumstances, behaviors, and environments. EHR data grew by 22% in this release, driven by expanded data sources including participant-mediated EHR submissions and health information exchange data.
"All of Us reflects the trust of people across the country who chose to contribute to research to benefit everyone," said All of Us Research Program CEO Josh Denny, M.D. "This release puts a richer dataset into the hands of scientists working on real clinical problems. This is how we advance the health of all Americans."
The power of All of Us lies not only in its size but in who is represented. More than 645,000 participants, 86% of the total, come from communities historically underrepresented in biomedical research, including older adults, women, people with disabilities, people of all races and ethnicities, and residents of rural and non-metropolitan areas. Participants span all 50 states and territories, reflecting more than 98% of U.S. three-digit ZIP codes.
The latest release also marks the program's entry into the multiomics era. For the first time, the dataset includes proteomics data from nearly 10,000 participants and RNA sequencing (RNAseq) data from nearly 9,000 participants, alongside long-read whole genome sequences from more than 14,500 participants. Additional multiomic data releases are planned later this year.
All of Us data has already fueled more than 1,400 peer-reviewed publications by nearly 23,000 researchers across all 50 states and around the globe. Recent findings include a first-of-its-kind clinical genetic test predicting inherited risk across eight cardiovascular conditions; validation of a low-cost prostate cancer risk model now being tested in a clinical trial of 5,000 U.S. veterans; and the identification of existing medications and novel genetic changes that may help prevent Alzheimer's disease. The program has also pioneered the largest research return of genetic results in history, delivering more than 733,000 personalized health-related DNA results to over 277,000 participants.
All of Us data is available to registered researchers at no cost, giving scientists at rural universities the same access as those at major research institutions.
"I see All of Us as a national treasure," said Dr. Bhattacharya. "This is an accessible, foundational platform that investigators at every career stage in institutions across the country can use to tackle our most pressing health challenges."
Registered researchers can access the latest release data, known as CDRv9, through the cloud-based researcher workbench at researchallofus.org.
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About the All of Us Research Program: The NIH All of Us Research Program is building one of the most diverse health databases in history to accelerate research that may improve health for generations to come. All of Us was authorized and funded through the 21st Century Cures Act. For more information, visit allofus.nih.gov.
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About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
NIH...Turning Discovery Into Health(R)
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Original text here: https://www.nih.gov/news-events/news-releases/nihs-all-us-research-program-now-largest-integrated-genomics-health-database-world
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NIH's All of Us Research Program is now the largest integrated genomics and health database in the world
Data from more than 747,000 participants is now available to scientists, powering next-generation discoveries in precision medicine.
-
The National Institutes of Health (NIH) has issued the most expansive data release in the history of its All of Us Research Program, making available data from more than 747,000 participants and establishing All of ... Show Full Article WASHINGTON, July 1 -- The U.S. Department of Health and Human Services National Institutes of Health issued the following news release: * * * NIH's All of Us Research Program is now the largest integrated genomics and health database in the world Data from more than 747,000 participants is now available to scientists, powering next-generation discoveries in precision medicine. - The National Institutes of Health (NIH) has issued the most expansive data release in the history of its All of Us Research Program, making available data from more than 747,000 participants and establishing All ofUs as the world's largest integrated genomic and electronic health record (EHR) database. The latest data release includes more than 535,000 whole genome sequences linked to nearly 482,000 electronic health records, a combination of genomic depth and clinical breadth unmatched by any research program in the world.
"There's a paradox at the heart of precision medicine," said NIH Director Jay Bhattacharya, M.D., Ph.D. "To tailor treatments to individuals, you actually need very large populations to uncover the patterns that connect genetics, lifestyle, and the environment to health outcomes. That is exactly what All of Us provides: research at unprecedented scale."
The new data issuance represents growth of more than 114,000 participants since the previous data version, bringing the program's total enrolled-participant count to over 883,000. The dataset now encompasses more than 1.3 billion genetic variants, 553,000 genotyping arrays, 96,000 structural variant records, and 600,000 physical measurements, alongside 747,000 survey responses capturing social circumstances, behaviors, and environments. EHR data grew by 22% in this release, driven by expanded data sources including participant-mediated EHR submissions and health information exchange data.
"All of Us reflects the trust of people across the country who chose to contribute to research to benefit everyone," said All of Us Research Program CEO Josh Denny, M.D. "This release puts a richer dataset into the hands of scientists working on real clinical problems. This is how we advance the health of all Americans."
The power of All of Us lies not only in its size but in who is represented. More than 645,000 participants, 86% of the total, come from communities historically underrepresented in biomedical research, including older adults, women, people with disabilities, people of all races and ethnicities, and residents of rural and non-metropolitan areas. Participants span all 50 states and territories, reflecting more than 98% of U.S. three-digit ZIP codes.
The latest release also marks the program's entry into the multiomics era. For the first time, the dataset includes proteomics data from nearly 10,000 participants and RNA sequencing (RNAseq) data from nearly 9,000 participants, alongside long-read whole genome sequences from more than 14,500 participants. Additional multiomic data releases are planned later this year.
All of Us data has already fueled more than 1,400 peer-reviewed publications by nearly 23,000 researchers across all 50 states and around the globe. Recent findings include a first-of-its-kind clinical genetic test predicting inherited risk across eight cardiovascular conditions; validation of a low-cost prostate cancer risk model now being tested in a clinical trial of 5,000 U.S. veterans; and the identification of existing medications and novel genetic changes that may help prevent Alzheimer's disease. The program has also pioneered the largest research return of genetic results in history, delivering more than 733,000 personalized health-related DNA results to over 277,000 participants.
All of Us data is available to registered researchers at no cost, giving scientists at rural universities the same access as those at major research institutions.
"I see All of Us as a national treasure," said Dr. Bhattacharya. "This is an accessible, foundational platform that investigators at every career stage in institutions across the country can use to tackle our most pressing health challenges."
Registered researchers can access the latest release data, known as CDRv9, through the cloud-based researcher workbench at researchallofus.org.
* * *
About the All of Us Research Program: The NIH All of Us Research Program is building one of the most diverse health databases in history to accelerate research that may improve health for generations to come. All of Us was authorized and funded through the 21st Century Cures Act. For more information, visit allofus.nih.gov.
* * *
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
NIH...Turning Discovery Into Health(R)
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Original text here: https://www.nih.gov/news-events/news-releases/nihs-all-us-research-program-now-largest-integrated-genomics-health-database-world
FDA Human Foods Program Issues Warning Letter to Flax & More
WASHINGTON, July 1 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Flax & More Corp. from its Human Foods Program:
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Recipient: Leonard Titayevsky, Flax & More Corporation, 10871 SW 188th St Unit 24, Cutler Bay, FL 33157-6801, United States
Issuing Office: Human Foods Program, United States
WARNING LETTER
CMS #722845
Dear Mr. Titayevsky:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 10871 SW 188th St Unit 24, Cutler Bay, FL 33157-6801, on October 21 through 29, 2025. ... Show Full Article WASHINGTON, July 1 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Flax & More Corp. from its Human Foods Program: * * * Recipient: Leonard Titayevsky, Flax & More Corporation, 10871 SW 188th St Unit 24, Cutler Bay, FL 33157-6801, United States Issuing Office: Human Foods Program, United States WARNING LETTER CMS #722845 Dear Mr. Titayevsky: The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 10871 SW 188th St Unit 24, Cutler Bay, FL 33157-6801, on October 21 through 29, 2025.Based on inspectional findings we have identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You can find the Act and FDA regulations through links on FDA's home page at www.fda.gov.
At the conclusion of the inspection on October 29, 2025, our investigator provided you with a Form FDA 483, Inspectional Observations (FDA 483). We acknowledge receipt of your response dated November 20, 2025, and we address your response below.
Adulterated Dietary Supplements
The inspection of your facility on October 21 through 29, 2025, identified serious violations of the FDA's regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause the dietary supplements, including (b)(4) products manufactured at your facility to be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. 342(g)(1)] because they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.
Your significant violations of the CGMP requirements are as follows:
1. You failed to ensure equipment and utensils you use have seams that are smoothly bonded or maintained to minimize accumulation of dirt, filth, organic material, particles of components or dietary supplements, or any other extraneous materials or contaminants, as required by 21 CFR 111.27(a)(4). Specifically, the hopper used on October 20, 2025, to manufacture dietary supplement product (b)(4) (lot (b)(4)) and was cleaned and sanitized (b)(4). However, on October 21, 2025, the hopper was observed to have an accumulation of dietary supplement residue in the seams of the equipment. Furthermore, (b)(4) (lot (b)(4)), is a product that contains the allergen wheat bran and you manufacture products that do not contain this ingredient on shared equipment.
We have reviewed your response to the FDA Form 483, dated November 17, 2025. In your response, you stated that you reviewed and made corrections to your sanitation procedures and logs and retrained staff. You also stated that you implemented (b)(4) sanitation inspections and conduct reviews of your cleaning logs. Your response is not sufficient in that you did not submit any evidence of corrective and preventive actions by providing copies of your updated cleaning SOPs or photos indicating that the hopper used in manufacture of your dietary supplement products has seams that are smoothly bonded to prevent accumulation of dirt, filth, organic material, particles of components or dietary supplements, or any other extraneous materials or contaminants, and that your cleaning and sanitizing procedures are effective.
2. You failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement you manufacture to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e). Specifically, you do not have product specifications for the identity, purity, strength, and composition of your (b)(4) finished dietary supplement products that you manufacture.
We have reviewed your response to the FDA Form 483, dated November 20, 2025, and find it inadequately addresses the violation. In your response, you provided the updated finished product specification sheet for the (b)(4) dietary supplement that you manufacture. Specifications for the strength and composition of the product were established; however, you did not establish specifications for identity and purity. You provided the strength values for each ingredient in the finished product; however, you did not provide the methodology used to determine the strength.
We note that the finished product specification sheet for your product is not consistent with the label claims. For example, the product label claims (b)(4); however, the product specification sheet does not include specifications for (b)(4). In addition, your response stated that you created comprehensive product specifications for all finished products; however, you provided product specifications for only the (b)(4) product.
3. You failed to ensure that each master manufacturing record included the required elements in accordance with 21 CFR 111.210. Specifically, your master manufacturing record for (b)(4) failed to include the following required elements of 21 CFR 111.210:
* A statement of theoretical yield of a manufactured dietary supplement expected at each point, step, or stage of the manufacturing process where control is needed to ensure the quality of the dietary supplement, and the expected yield when you finish manufacturing the dietary supplement, including the maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary and material review is conducted and disposition decision is made [21 CFR 111.210(f)]; and
* Procedures for sampling and a cross-reference to procedures for tests or examinations [21 CFR 11.210(h)(2)].
This letter is not intended to be an all-inclusive statement of violations that may exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including applicable FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your written reply should be directed to Rebecca Allen, United States Food and Drug Administration, Human Foods Program, Office of Enforcement, 5001 Campus Drive, College Park, Maryland 20740-3835 or via email at HFP-OCE-DietarySupplements@fda.hhs.gov. Please reference CMS #722845 on any submissions and within the subject line of any emails to us. If you have any questions, you may email at HFP-OCE-DietarySupplements@fda.hhs.gov.
Sincerely,
/S/ Maria S. Knirk, JD, MBA, Director, Office of Enforcement, Office of Compliance and Enforcement, Human Foods Program
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Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/flax-more-corporation-722845-05122026
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Recipient: Leonard Titayevsky, Flax & More Corporation, 10871 SW 188th St Unit 24, Cutler Bay, FL 33157-6801, United States
Issuing Office: Human Foods Program, United States
WARNING LETTER
CMS #722845
Dear Mr. Titayevsky:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 10871 SW 188th St Unit 24, Cutler Bay, FL 33157-6801, on October 21 through 29, 2025. ... Show Full Article WASHINGTON, July 1 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Flax & More Corp. from its Human Foods Program: * * * Recipient: Leonard Titayevsky, Flax & More Corporation, 10871 SW 188th St Unit 24, Cutler Bay, FL 33157-6801, United States Issuing Office: Human Foods Program, United States WARNING LETTER CMS #722845 Dear Mr. Titayevsky: The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 10871 SW 188th St Unit 24, Cutler Bay, FL 33157-6801, on October 21 through 29, 2025.Based on inspectional findings we have identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You can find the Act and FDA regulations through links on FDA's home page at www.fda.gov.
At the conclusion of the inspection on October 29, 2025, our investigator provided you with a Form FDA 483, Inspectional Observations (FDA 483). We acknowledge receipt of your response dated November 20, 2025, and we address your response below.
Adulterated Dietary Supplements
The inspection of your facility on October 21 through 29, 2025, identified serious violations of the FDA's regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause the dietary supplements, including (b)(4) products manufactured at your facility to be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. 342(g)(1)] because they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.
Your significant violations of the CGMP requirements are as follows:
1. You failed to ensure equipment and utensils you use have seams that are smoothly bonded or maintained to minimize accumulation of dirt, filth, organic material, particles of components or dietary supplements, or any other extraneous materials or contaminants, as required by 21 CFR 111.27(a)(4). Specifically, the hopper used on October 20, 2025, to manufacture dietary supplement product (b)(4) (lot (b)(4)) and was cleaned and sanitized (b)(4). However, on October 21, 2025, the hopper was observed to have an accumulation of dietary supplement residue in the seams of the equipment. Furthermore, (b)(4) (lot (b)(4)), is a product that contains the allergen wheat bran and you manufacture products that do not contain this ingredient on shared equipment.
We have reviewed your response to the FDA Form 483, dated November 17, 2025. In your response, you stated that you reviewed and made corrections to your sanitation procedures and logs and retrained staff. You also stated that you implemented (b)(4) sanitation inspections and conduct reviews of your cleaning logs. Your response is not sufficient in that you did not submit any evidence of corrective and preventive actions by providing copies of your updated cleaning SOPs or photos indicating that the hopper used in manufacture of your dietary supplement products has seams that are smoothly bonded to prevent accumulation of dirt, filth, organic material, particles of components or dietary supplements, or any other extraneous materials or contaminants, and that your cleaning and sanitizing procedures are effective.
2. You failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement you manufacture to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e). Specifically, you do not have product specifications for the identity, purity, strength, and composition of your (b)(4) finished dietary supplement products that you manufacture.
We have reviewed your response to the FDA Form 483, dated November 20, 2025, and find it inadequately addresses the violation. In your response, you provided the updated finished product specification sheet for the (b)(4) dietary supplement that you manufacture. Specifications for the strength and composition of the product were established; however, you did not establish specifications for identity and purity. You provided the strength values for each ingredient in the finished product; however, you did not provide the methodology used to determine the strength.
We note that the finished product specification sheet for your product is not consistent with the label claims. For example, the product label claims (b)(4); however, the product specification sheet does not include specifications for (b)(4). In addition, your response stated that you created comprehensive product specifications for all finished products; however, you provided product specifications for only the (b)(4) product.
3. You failed to ensure that each master manufacturing record included the required elements in accordance with 21 CFR 111.210. Specifically, your master manufacturing record for (b)(4) failed to include the following required elements of 21 CFR 111.210:
* A statement of theoretical yield of a manufactured dietary supplement expected at each point, step, or stage of the manufacturing process where control is needed to ensure the quality of the dietary supplement, and the expected yield when you finish manufacturing the dietary supplement, including the maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary and material review is conducted and disposition decision is made [21 CFR 111.210(f)]; and
* Procedures for sampling and a cross-reference to procedures for tests or examinations [21 CFR 11.210(h)(2)].
This letter is not intended to be an all-inclusive statement of violations that may exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including applicable FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your written reply should be directed to Rebecca Allen, United States Food and Drug Administration, Human Foods Program, Office of Enforcement, 5001 Campus Drive, College Park, Maryland 20740-3835 or via email at HFP-OCE-DietarySupplements@fda.hhs.gov. Please reference CMS #722845 on any submissions and within the subject line of any emails to us. If you have any questions, you may email at HFP-OCE-DietarySupplements@fda.hhs.gov.
Sincerely,
/S/ Maria S. Knirk, JD, MBA, Director, Office of Enforcement, Office of Compliance and Enforcement, Human Foods Program
* * *
Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/flax-more-corporation-722845-05122026
FDA Center for Drug Evaluation & Research Issues Warning Letter to Wizcure Pharmaa
WASHINGTON, July 1 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Wizcure Pharmaa Private Limited from its Center for Drug Evaluation and Research:
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Recipient: Mr. Ashish Arun Dange, Managing Director, Wizcure Pharmaa Private Limited, PGN 02-1403, Emaar Palm Gardens Sector 83, Gurgaon 122004 Haryana, India
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
Warning Letter 320-26-97
Dear Mr. Dange:
The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, ... Show Full Article WASHINGTON, July 1 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Wizcure Pharmaa Private Limited from its Center for Drug Evaluation and Research: * * * Recipient: Mr. Ashish Arun Dange, Managing Director, Wizcure Pharmaa Private Limited, PGN 02-1403, Emaar Palm Gardens Sector 83, Gurgaon 122004 Haryana, India Issuing Office: Center for Drug Evaluation and Research (CDER), United States Warning Letter 320-26-97 Dear Mr. Dange: The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility,Wizcure Pharmaa Private Limited, 3030304532, located at H-881, Phase III, RIICO Industrial Area Bhiwadi, Rajasthan, India, from December 3 to 10, 2025.
This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).
We reviewed your December 30, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.
During our inspection, our investigators observed specific violations including, but not limited to, the following.
1. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)).
You lacked complete and original laboratory data demonstrating that the required testing was performed.
For example, our investigator observed (b)(4) personnel monitoring microbial plates in your laboratory incubator with visible microbial growth. The next day, our investigator observed microbial plates with the same identification information with no growth. Both management and a microbiologist confirmed that the original microbial plates were discarded and replaced with new plates. This false data misrepresented the ISO 5 environmental conditions of your aseptic processing line.
Additionally, our inspection found that you frequently failed to collect environmental monitoring, personnel monitoring, and (b)(4) samples, as required by your procedure. For example, personnel monitoring contact plates were not collected on November 29, 2025, during the manufacturing of (b)(4) solution USP (b)(4) batches (b)(4) and (b)(4).
We also identified critical discrepancies in your sample test results. We found that you failed to reliably incubate samples and record accurate microbial counts. For example, our inspection repeatedly found unreliable and incorrect microbiology data, including, but not limited to, environmental monitoring samples.
In addition, we identified other significant discrepancies in sample description, identification, and reconcilability. Our investigators also found laboratory forms were pre-filled with microbial testing information (e.g., sterility and (b)(4) testing results), further demonstrating untrustworthy documentation. Significantly, when your firm actually obtained environmental monitoring samples and we closely tracked the plates during our inspection, we noted several instances in which microbial contamination was present in your ISO 5 processing environment.
Our inspectional findings indicate serious recurring data integrity breaches in your laboratory relating to critical microbiological tests and monitoring.
Microbial monitoring and testing are essential quality control steps that are integral in preventing distribution of unsafe products. Such programs provide critical information on the state of control of the aseptic processing operation. Substitution of unreliable or false results fundamentally compromises a facility's ability to identify risks to product sterility.
In your response, you acknowledge confirmation of these data integrity breaches based on interviews with personnel and review of documentation. Your firm suspended manufacturing and has initiated a protocol-driven remediation program. Your firm has also engaged an independent third-party consultant to help with a comprehensive investigation and identification of corrective actions and preventive actions (CAPA).
Your response is inadequate. While you acknowledge the systemic nature of your data integrity problems and have initiated an investigation, your response does not sufficiently address organizational causes of the observed data integrity practice. For example, you do not provide evidence that your quality unit organization has the resources and expertise to perform its function, including detecting deviations relating to data integrity and sterile drug operations.
Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. See FDA's guidance document Data Integrity and Compliance With Drug CGMP for guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-integrity-and-compliance-drug-cgmp-questions-and-answers.
In response to this letter, provide:
* A comprehensive, independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.
* A comprehensive, independent assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient. Include a detailed CAPA plan that comprehensively remediates your firm's documentation practices to ensure you retain contemporaneous, attributable, legible, complete, original, and accurate records throughout your operation.
* A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a data integrity deviation and analyses of the risks posed by ongoing operations.
* A comprehensive CAPA, overseen by a qualified consultant, for handling microbiological sampling media to ensure robust and reliable data. Establish a system that ensures uninterrupted custody and full reconciliation of all microbiological samples including, but not limited to:
- unique labeling of each sample
- signatures of all staff who handle the sample
- complete tracking of sample integrity and custody
- date and time of each activity (e.g., sample collection, transport, delivery, incubation, removal from incubator)
- digital time-stamped photos of all plates
- signatures of personnel performing reading of microbial counts
- provisions for verifications and routine quality assurance oversight.
* An independent assessment and remediation plan for your CAPA program. Provide a report that evaluates whether the program includes effective root cause analysis, ensures CAPA effectiveness, analyzes investigations trends, improves the CAPA program whenever needed, ensures final quality unit decision authority, and is fully supported by executive management.
* An independent review of your microbial effectiveness testing program, including assuring that all multi-use products are evaluated using sound microbial effectiveness study protocols and that each formulation is suitable throughout its use period.
2. Your firm failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas (21 CFR 211.42(c)(10).
Your aseptic manufacturing filling line used to produce over-the-counter (OTC) sterile drug products is inadequate.
For example, the inspection documented that your filling line has no physical barrier separating and protecting your ISO 5 (Grade A) aseptic filling line from the surrounding ISO 7 (Grade B) room and its personnel. The absence of a physical barrier separating the ISO 5 (Grade A) filling zone from the ISO 7 (Grade B) surrounding environment creates an unacceptable risk to product sterility.
Furthermore, several equipment parts in direct contact with drug product, containers, and closures were not sterilized.
It is essential that the ISO 5 (Grade A) environment continuously maintains an extremely high level of air cleanliness to protect the exposed sterile drug product from contamination. Without proper physical separation, the integrity of the aseptic processing environment cannot be reliably maintained as air currents, personnel movement, and other variables in the less-controlled ISO 7 space can directly convey contamination into the ISO 5 zone.
In addition, to ensure sterility, it is imperative that only sterile equipment comes into direct contact with the sterile formulation, containers, and closures.
Your aseptic processing room also had inadequate space to accommodate appropriate ergonomics, personnel flow, and material flow. Our inspection also found that your processing equipment was in poor state of repair, as detailed later in this letter.
Finally, you lacked a meaningful environmental monitoring (e.g., critical surfaces, viable air) and personnel monitoring program for your aseptic processing line.
Aseptic manufacturing processes operations must be performed in specifically defined areas of adequate size and vigilantly monitored to promptly identify microbial hazards before there is a non-sterility consequence.
In your response, you commit to replacing your (b)(4) filling line with a restricted access barrier system (RABS) and implementing a comprehensive environmental monitoring program.
Your response is inadequate. Your response lacks a comprehensive evaluation of aseptic processing facility suitability, including but not limited to cleanroom design.
In response to this letter, provide:
* A comprehensive independent risk assessment of all contamination hazards with respect to your aseptic processes, equipment, and facilities, that includes, but is not limited to:
- all human interactions within the ISO 5 area (e.g., risk reduction or elimination of manual interventions wherever possible)
- equipment placement and suitability, including ergonomics for each human interaction and sufficient cleanroom space
- air quality in the ISO 5 area and surrounding room including, but not limited to, air volume and flow
- reduction or elimination of aseptic manipulations
- facility layout
- personnel flows and material flows throughout all rooms used to conduct and support sterile operations
- specific CAPA recommendations that will comprehensively address the design and control hazards identified in the risk assessment
* A detailed remediation plan with timelines to address the findings of the contamination hazards risk assessment. Describe specific tangible improvements to be made to aseptic processing operation design and control at your facility and explain how this CAPA plan will robustly remediate your deficient sterile manufacturing operations. Include comprehensive changes to the design of both your aseptic processing lines and cleanrooms. Also, describe your plans for qualification and validation of your extensively remediated operations.
* An independent, comprehensive review of your environmental monitoring program to ensure vigilant, timely detection and response to potential product contamination hazards in your manufacturing environment. This assessment should include, but not be limited to:
- establishing appropriate limits
- sampling methods
- sampling locations and frequencies
- trend analysis
- appropriate investigation of deviations and adverse trends
- and a comprehensive CAPA plan based on the findings of the assessment.
* A comprehensive, independent assessment of the design and control of your firm's manufacturing operations with a detailed and thorough review of all microbiological hazards.
* Your CAPA plan to implement routine, vigilant operations management oversight of facilities and equipment. This plan should incorporate oversight from a qualified independent consultant and ensure, among other things, prompt detection of equipment/facilities performance issues, effective execution of repairs, adherence to appropriate preventive maintenance schedules, timely technological upgrades to the equipment/facility infrastructure, and improved systems for ongoing management review.
3. Your firm failed to follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).
Your aseptic process simulations (media fills) were not sufficiently representative of commercial aseptic manufacturing operations. Also, batch records lacked documentation of all personnel present and interventions conducted during aseptic manufacturing.
Additionally, the airflow visualization (i.e., smoke studies) was not performed under dynamic conditions to assess the hazards posed by interventions into the aseptic processing line. Your static airflow visualization addressed areas surrounding filling room (b)(4). Notably, we also observed aseptic operator deviations including, but not limited to, wearing safety glasses with exposed skin during aseptic production.
In your response, you acknowledge that media fills did not sufficiently document operations and that previously executed media fills were not representative of aseptic processing conditions.
Your response is inadequate. You lack sufficient details regarding batch record improvements to document the type, quantity, and duration of interventions during commercial batch production as well as media fill simulations.
See FDA's guidance document Sterile Drug Products Produced by Aseptic Processing--Current Good Manufacturing Practice to help you meet the CGMP requirements when manufacturing sterile drugs using aseptic processing at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/sterile-drug-products-produced-aseptic-processing-current-good-manufacturing-practice.
In response to this letter, provide the following:
* Perform a critical evaluation of airflow unidirectionality in your aseptic process with the assistance of a qualified consultant. Ensure smoke studies are conducted under dynamic conditions with thorough and complete evaluations of aseptic processing line airflow unidirectionality including the impact of dynamic interactions and aseptic interventions. These thorough smoke studies should be performed after you remediate your aseptic operation and conducted using proper practices (e.g., neutrally buoyant media) to appropriately visualize airflow.
* Your plan to ensure appropriate aseptic practices and cleanroom behavior. Include steps to ensure routine and effective supervisory oversight for all production batches. Also describe the frequency of quality unit oversight (e.g., audit) during aseptic processing and its support operations.
* A comprehensive, independent assessment of the qualifications and competencies of operations and quality assurance management to conduct their job duties throughout your aseptic manufacturing operations.
* A comprehensive assessment and remediation plan to ensure your quality unit (QU) is given the authority and resources to effectively function. The assessment should also include, but not be limited to:
- a determination of whether procedures used by your firm are robust and appropriate
- provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices
- a complete and final review of each batch and its related information before the QU disposition decision
- oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.
4. Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)).
You failed to adequately maintain your manufacturing equipment. For example, your filling line was observed with apparent rust on the critical aseptic processing equipment, including the (b)(4).
Also, our investigators observed stains and apparent rust on the HEPA filters and their diffuser grids above the filling line.
We are concerned with your management's lack of oversight of manufacturing operations that allowed insanitary equipment to be used in sterile drug manufacturing.
An effective equipment management program requires a proactive lifecycle approach with systematic monitoring, maintenance, and timely replacement to ensure continued process capability. Pharmaceutical quality systems must integrate equipment performance data, maintenance oversight, and risk assessment to drive timely CAPA.
In your response, you acknowledged the presence of what appeared to be rust and deterioration in the (b)(4) filling line. You attributed the root cause to a systematic gap in equipment lifecycle management. You indicate that you conducted an assessment and remediation of equipment.
Your response is inadequate. While you acknowledge the identified systemic gaps in equipment lifecycle management, your corrective action appears to include limited remediations. Also, you did not conduct a retrospective risk assessment for batches that were processed using equipment in unsuitable condition for manufacturing sterile drug products.
In response to this letter, provide the following:
* A remediation plan that better assures ongoing management oversight throughout the manufacturing lifecycle of all drug products. Provide a more data-driven and scientifically sound program that identifies sources of process variability and assures that manufacturing (including both production and packaging) operations meet appropriate parameters and quality standards. This includes, but is not limited to, evaluating suitability of equipment for its intended use, ensuring quality of input materials, determining the capability and reliability of each manufacturing process step and its controls, and vigilant ongoing monitoring of process performance and product quality.
* A summary of updated SOPs that ensure an appropriate program is in place for verification of equipment condition and validation of cleaning procedures for products, processes, and equipment.
* Provide a detailed remediation plan, performance protocols, and written procedures that include a defined timeline, milestones, and documentation to conduct the qualification of equipment (e.g., aseptic filling lines) and facilities (e.g., aseptic filling rooms).
Data Integrity Remediation
Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. See FDA's guidance document Data Integrity and Compliance With Drug CGMP: Questions and Answers for guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-integrity-and-compliance-drug-cgmp-questions-and-answers.
We acknowledge that you are using an independent third-party consultant to audit your operation and assist in meeting FDA requirements. In response to this letter, provide:
* A comprehensive investigation into the extent of the inaccuracies in data records and reporting. Your investigation should include:
- A detailed investigation protocol and methodology; a summary of all laboratories, manufacturing operations, and systems to be covered by the assessment; and a justification for any part of your operation that you propose to exclude.
- Interviews of current and former employees to identify the nature, scope, and root cause of data inaccuracies. We recommend that these interviews be conducted by a qualified third party.
- An assessment of the extent of data integrity deficiencies at your facility. Identify omissions, alterations, deletions, record destruction, non-contemporaneous record completion, and other deficiencies. Describe all parts of your facility's operations in which you discovered data integrity deviations.
- A comprehensive retrospective evaluation of the nature of the testing/manufacturing/other data integrity deficiencies. We recommend that a qualified third party with specific expertise in the area where potential breaches were identified should evaluate all data integrity deviations.
* A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a data integrity deviations and analyses of the risks posed by ongoing operations.
* A management strategy for your firm that includes the details of your global corrective action and preventive action plan. Your strategy should include:
- A detailed corrective action plan that describes how you intend to ensure the reliability and completeness of all data including analytical data, manufacturing records, and all data submitted to FDA.
- A comprehensive description of the root causes of your data integrity deviations including evidence that the scope and depth of the current action plan is commensurate with the findings of the investigation and risk assessment. Indicate whether individuals responsible for data integrity deviations remain able to influence CGMP-related or drug application data at your firm.
- Interim measures describing the actions you have taken or will take to protect patients and to ensure the quality of your drugs, such as notifying your customers, recalling product, conducting additional testing, adding lots to your stability programs to assure stability, drug application actions, and enhanced complaint monitoring.
- Long-term measures describing any remediation efforts and enhancements to procedures, processes, methods, controls, systems, management oversight, and human resources (e.g., training, staffing improvements) designed to ensure the integrity of your company's data.
- A commitment to have a qualified consultant conduct extensive annual audits, for at least two years, to assist in evaluating CAPA effectiveness after you have executed your data integrity remediation protocol.
- Inform FDA if you will be hiring a chief integrity officer who is fully empowered to receive anonymous complaints from employees reporting data integrity concerns and with the authority to ensure any potential breach is promptly investigated by independent quality assurance function, along with expertise from outside entities whenever needed.
- A status report for any of the above activities already underway or completed.
Drug Production Suspended
We acknowledge your commitment to suspend production of all (b)(4) OTC (b)(4) drug products for the U.S. market. In response to this letter, clarify whether you intend to resume manufacturing drugs for the U.S. market at this facility in the future.
If you plan to resume any manufacturing operations regulated under the FD&C Act, notify this office before resuming your drug manufacturing operations. You are responsible for resolving all deficiencies and systemic flaws to ensure your firm is capable of ongoing CGMP compliance. In your notification to the Agency, provide a summary of your remediations to demonstrate that you have appropriately completed all CAPAs.
Quality System
Significant findings in this letter demonstrate that your firm does not operate an effective quality system in accord with CGMP. In addition to the lack of effective management oversight of your production, laboratory operations, we found your quality unit is not enabled to exercise proper authority and has insufficiently implemented its responsibilities. Executive management should immediately and comprehensively assess your company's operations to ensure that your systems, processes, and products conform to FDA requirements.
CGMP Consultant Recommended
Based upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements if your firm intends to resume manufacturing drugs for the U.S. market. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm's compliance status with FDA.
Your use of a consultant does not relieve your firm's obligation to comply with CGMP. Your firm's executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.
Drug Recall
On December 18, 2025, FDA held a teleconference with you recommending you remove any batches of (b)(4) OTC (b)(4) drug products and (b)(4) from the U.S. market.
On December 30, 2025, you communicated your commitment to cease manufacturing and distribution of all drugs for U.S. market. You also agreed to voluntary recall all drugs in current distribution in U.S.
On (b)(4), you issued a voluntary recall of all (b)(4).
Conclusion
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.
FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on December 23, 2025.
Correct any violations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any violations.
Failure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at Wizcure Pharmaa Private Limited located at H-881, Phase III, RIICO Industrial Area Bhiwadi, Rajasthan, India, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).
This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.
Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3030304532 and ATTN: Rafael E. Arroyo.
Sincerely,
/S/ Francis Godwin, Director, Office of Manufacturing Quality, Office of Compliance, Center for Drug Evaluation and Research
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Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/wizcure-pharmaa-private-limited-726378-06242026
* * *
Recipient: Mr. Ashish Arun Dange, Managing Director, Wizcure Pharmaa Private Limited, PGN 02-1403, Emaar Palm Gardens Sector 83, Gurgaon 122004 Haryana, India
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
Warning Letter 320-26-97
Dear Mr. Dange:
The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, ... Show Full Article WASHINGTON, July 1 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Wizcure Pharmaa Private Limited from its Center for Drug Evaluation and Research: * * * Recipient: Mr. Ashish Arun Dange, Managing Director, Wizcure Pharmaa Private Limited, PGN 02-1403, Emaar Palm Gardens Sector 83, Gurgaon 122004 Haryana, India Issuing Office: Center for Drug Evaluation and Research (CDER), United States Warning Letter 320-26-97 Dear Mr. Dange: The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility,Wizcure Pharmaa Private Limited, 3030304532, located at H-881, Phase III, RIICO Industrial Area Bhiwadi, Rajasthan, India, from December 3 to 10, 2025.
This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).
We reviewed your December 30, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.
During our inspection, our investigators observed specific violations including, but not limited to, the following.
1. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)).
You lacked complete and original laboratory data demonstrating that the required testing was performed.
For example, our investigator observed (b)(4) personnel monitoring microbial plates in your laboratory incubator with visible microbial growth. The next day, our investigator observed microbial plates with the same identification information with no growth. Both management and a microbiologist confirmed that the original microbial plates were discarded and replaced with new plates. This false data misrepresented the ISO 5 environmental conditions of your aseptic processing line.
Additionally, our inspection found that you frequently failed to collect environmental monitoring, personnel monitoring, and (b)(4) samples, as required by your procedure. For example, personnel monitoring contact plates were not collected on November 29, 2025, during the manufacturing of (b)(4) solution USP (b)(4) batches (b)(4) and (b)(4).
We also identified critical discrepancies in your sample test results. We found that you failed to reliably incubate samples and record accurate microbial counts. For example, our inspection repeatedly found unreliable and incorrect microbiology data, including, but not limited to, environmental monitoring samples.
In addition, we identified other significant discrepancies in sample description, identification, and reconcilability. Our investigators also found laboratory forms were pre-filled with microbial testing information (e.g., sterility and (b)(4) testing results), further demonstrating untrustworthy documentation. Significantly, when your firm actually obtained environmental monitoring samples and we closely tracked the plates during our inspection, we noted several instances in which microbial contamination was present in your ISO 5 processing environment.
Our inspectional findings indicate serious recurring data integrity breaches in your laboratory relating to critical microbiological tests and monitoring.
Microbial monitoring and testing are essential quality control steps that are integral in preventing distribution of unsafe products. Such programs provide critical information on the state of control of the aseptic processing operation. Substitution of unreliable or false results fundamentally compromises a facility's ability to identify risks to product sterility.
In your response, you acknowledge confirmation of these data integrity breaches based on interviews with personnel and review of documentation. Your firm suspended manufacturing and has initiated a protocol-driven remediation program. Your firm has also engaged an independent third-party consultant to help with a comprehensive investigation and identification of corrective actions and preventive actions (CAPA).
Your response is inadequate. While you acknowledge the systemic nature of your data integrity problems and have initiated an investigation, your response does not sufficiently address organizational causes of the observed data integrity practice. For example, you do not provide evidence that your quality unit organization has the resources and expertise to perform its function, including detecting deviations relating to data integrity and sterile drug operations.
Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. See FDA's guidance document Data Integrity and Compliance With Drug CGMP for guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-integrity-and-compliance-drug-cgmp-questions-and-answers.
In response to this letter, provide:
* A comprehensive, independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.
* A comprehensive, independent assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient. Include a detailed CAPA plan that comprehensively remediates your firm's documentation practices to ensure you retain contemporaneous, attributable, legible, complete, original, and accurate records throughout your operation.
* A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a data integrity deviation and analyses of the risks posed by ongoing operations.
* A comprehensive CAPA, overseen by a qualified consultant, for handling microbiological sampling media to ensure robust and reliable data. Establish a system that ensures uninterrupted custody and full reconciliation of all microbiological samples including, but not limited to:
- unique labeling of each sample
- signatures of all staff who handle the sample
- complete tracking of sample integrity and custody
- date and time of each activity (e.g., sample collection, transport, delivery, incubation, removal from incubator)
- digital time-stamped photos of all plates
- signatures of personnel performing reading of microbial counts
- provisions for verifications and routine quality assurance oversight.
* An independent assessment and remediation plan for your CAPA program. Provide a report that evaluates whether the program includes effective root cause analysis, ensures CAPA effectiveness, analyzes investigations trends, improves the CAPA program whenever needed, ensures final quality unit decision authority, and is fully supported by executive management.
* An independent review of your microbial effectiveness testing program, including assuring that all multi-use products are evaluated using sound microbial effectiveness study protocols and that each formulation is suitable throughout its use period.
2. Your firm failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas (21 CFR 211.42(c)(10).
Your aseptic manufacturing filling line used to produce over-the-counter (OTC) sterile drug products is inadequate.
For example, the inspection documented that your filling line has no physical barrier separating and protecting your ISO 5 (Grade A) aseptic filling line from the surrounding ISO 7 (Grade B) room and its personnel. The absence of a physical barrier separating the ISO 5 (Grade A) filling zone from the ISO 7 (Grade B) surrounding environment creates an unacceptable risk to product sterility.
Furthermore, several equipment parts in direct contact with drug product, containers, and closures were not sterilized.
It is essential that the ISO 5 (Grade A) environment continuously maintains an extremely high level of air cleanliness to protect the exposed sterile drug product from contamination. Without proper physical separation, the integrity of the aseptic processing environment cannot be reliably maintained as air currents, personnel movement, and other variables in the less-controlled ISO 7 space can directly convey contamination into the ISO 5 zone.
In addition, to ensure sterility, it is imperative that only sterile equipment comes into direct contact with the sterile formulation, containers, and closures.
Your aseptic processing room also had inadequate space to accommodate appropriate ergonomics, personnel flow, and material flow. Our inspection also found that your processing equipment was in poor state of repair, as detailed later in this letter.
Finally, you lacked a meaningful environmental monitoring (e.g., critical surfaces, viable air) and personnel monitoring program for your aseptic processing line.
Aseptic manufacturing processes operations must be performed in specifically defined areas of adequate size and vigilantly monitored to promptly identify microbial hazards before there is a non-sterility consequence.
In your response, you commit to replacing your (b)(4) filling line with a restricted access barrier system (RABS) and implementing a comprehensive environmental monitoring program.
Your response is inadequate. Your response lacks a comprehensive evaluation of aseptic processing facility suitability, including but not limited to cleanroom design.
In response to this letter, provide:
* A comprehensive independent risk assessment of all contamination hazards with respect to your aseptic processes, equipment, and facilities, that includes, but is not limited to:
- all human interactions within the ISO 5 area (e.g., risk reduction or elimination of manual interventions wherever possible)
- equipment placement and suitability, including ergonomics for each human interaction and sufficient cleanroom space
- air quality in the ISO 5 area and surrounding room including, but not limited to, air volume and flow
- reduction or elimination of aseptic manipulations
- facility layout
- personnel flows and material flows throughout all rooms used to conduct and support sterile operations
- specific CAPA recommendations that will comprehensively address the design and control hazards identified in the risk assessment
* A detailed remediation plan with timelines to address the findings of the contamination hazards risk assessment. Describe specific tangible improvements to be made to aseptic processing operation design and control at your facility and explain how this CAPA plan will robustly remediate your deficient sterile manufacturing operations. Include comprehensive changes to the design of both your aseptic processing lines and cleanrooms. Also, describe your plans for qualification and validation of your extensively remediated operations.
* An independent, comprehensive review of your environmental monitoring program to ensure vigilant, timely detection and response to potential product contamination hazards in your manufacturing environment. This assessment should include, but not be limited to:
- establishing appropriate limits
- sampling methods
- sampling locations and frequencies
- trend analysis
- appropriate investigation of deviations and adverse trends
- and a comprehensive CAPA plan based on the findings of the assessment.
* A comprehensive, independent assessment of the design and control of your firm's manufacturing operations with a detailed and thorough review of all microbiological hazards.
* Your CAPA plan to implement routine, vigilant operations management oversight of facilities and equipment. This plan should incorporate oversight from a qualified independent consultant and ensure, among other things, prompt detection of equipment/facilities performance issues, effective execution of repairs, adherence to appropriate preventive maintenance schedules, timely technological upgrades to the equipment/facility infrastructure, and improved systems for ongoing management review.
3. Your firm failed to follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).
Your aseptic process simulations (media fills) were not sufficiently representative of commercial aseptic manufacturing operations. Also, batch records lacked documentation of all personnel present and interventions conducted during aseptic manufacturing.
Additionally, the airflow visualization (i.e., smoke studies) was not performed under dynamic conditions to assess the hazards posed by interventions into the aseptic processing line. Your static airflow visualization addressed areas surrounding filling room (b)(4). Notably, we also observed aseptic operator deviations including, but not limited to, wearing safety glasses with exposed skin during aseptic production.
In your response, you acknowledge that media fills did not sufficiently document operations and that previously executed media fills were not representative of aseptic processing conditions.
Your response is inadequate. You lack sufficient details regarding batch record improvements to document the type, quantity, and duration of interventions during commercial batch production as well as media fill simulations.
See FDA's guidance document Sterile Drug Products Produced by Aseptic Processing--Current Good Manufacturing Practice to help you meet the CGMP requirements when manufacturing sterile drugs using aseptic processing at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/sterile-drug-products-produced-aseptic-processing-current-good-manufacturing-practice.
In response to this letter, provide the following:
* Perform a critical evaluation of airflow unidirectionality in your aseptic process with the assistance of a qualified consultant. Ensure smoke studies are conducted under dynamic conditions with thorough and complete evaluations of aseptic processing line airflow unidirectionality including the impact of dynamic interactions and aseptic interventions. These thorough smoke studies should be performed after you remediate your aseptic operation and conducted using proper practices (e.g., neutrally buoyant media) to appropriately visualize airflow.
* Your plan to ensure appropriate aseptic practices and cleanroom behavior. Include steps to ensure routine and effective supervisory oversight for all production batches. Also describe the frequency of quality unit oversight (e.g., audit) during aseptic processing and its support operations.
* A comprehensive, independent assessment of the qualifications and competencies of operations and quality assurance management to conduct their job duties throughout your aseptic manufacturing operations.
* A comprehensive assessment and remediation plan to ensure your quality unit (QU) is given the authority and resources to effectively function. The assessment should also include, but not be limited to:
- a determination of whether procedures used by your firm are robust and appropriate
- provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices
- a complete and final review of each batch and its related information before the QU disposition decision
- oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.
4. Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)).
You failed to adequately maintain your manufacturing equipment. For example, your filling line was observed with apparent rust on the critical aseptic processing equipment, including the (b)(4).
Also, our investigators observed stains and apparent rust on the HEPA filters and their diffuser grids above the filling line.
We are concerned with your management's lack of oversight of manufacturing operations that allowed insanitary equipment to be used in sterile drug manufacturing.
An effective equipment management program requires a proactive lifecycle approach with systematic monitoring, maintenance, and timely replacement to ensure continued process capability. Pharmaceutical quality systems must integrate equipment performance data, maintenance oversight, and risk assessment to drive timely CAPA.
In your response, you acknowledged the presence of what appeared to be rust and deterioration in the (b)(4) filling line. You attributed the root cause to a systematic gap in equipment lifecycle management. You indicate that you conducted an assessment and remediation of equipment.
Your response is inadequate. While you acknowledge the identified systemic gaps in equipment lifecycle management, your corrective action appears to include limited remediations. Also, you did not conduct a retrospective risk assessment for batches that were processed using equipment in unsuitable condition for manufacturing sterile drug products.
In response to this letter, provide the following:
* A remediation plan that better assures ongoing management oversight throughout the manufacturing lifecycle of all drug products. Provide a more data-driven and scientifically sound program that identifies sources of process variability and assures that manufacturing (including both production and packaging) operations meet appropriate parameters and quality standards. This includes, but is not limited to, evaluating suitability of equipment for its intended use, ensuring quality of input materials, determining the capability and reliability of each manufacturing process step and its controls, and vigilant ongoing monitoring of process performance and product quality.
* A summary of updated SOPs that ensure an appropriate program is in place for verification of equipment condition and validation of cleaning procedures for products, processes, and equipment.
* Provide a detailed remediation plan, performance protocols, and written procedures that include a defined timeline, milestones, and documentation to conduct the qualification of equipment (e.g., aseptic filling lines) and facilities (e.g., aseptic filling rooms).
Data Integrity Remediation
Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. See FDA's guidance document Data Integrity and Compliance With Drug CGMP: Questions and Answers for guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-integrity-and-compliance-drug-cgmp-questions-and-answers.
We acknowledge that you are using an independent third-party consultant to audit your operation and assist in meeting FDA requirements. In response to this letter, provide:
* A comprehensive investigation into the extent of the inaccuracies in data records and reporting. Your investigation should include:
- A detailed investigation protocol and methodology; a summary of all laboratories, manufacturing operations, and systems to be covered by the assessment; and a justification for any part of your operation that you propose to exclude.
- Interviews of current and former employees to identify the nature, scope, and root cause of data inaccuracies. We recommend that these interviews be conducted by a qualified third party.
- An assessment of the extent of data integrity deficiencies at your facility. Identify omissions, alterations, deletions, record destruction, non-contemporaneous record completion, and other deficiencies. Describe all parts of your facility's operations in which you discovered data integrity deviations.
- A comprehensive retrospective evaluation of the nature of the testing/manufacturing/other data integrity deficiencies. We recommend that a qualified third party with specific expertise in the area where potential breaches were identified should evaluate all data integrity deviations.
* A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a data integrity deviations and analyses of the risks posed by ongoing operations.
* A management strategy for your firm that includes the details of your global corrective action and preventive action plan. Your strategy should include:
- A detailed corrective action plan that describes how you intend to ensure the reliability and completeness of all data including analytical data, manufacturing records, and all data submitted to FDA.
- A comprehensive description of the root causes of your data integrity deviations including evidence that the scope and depth of the current action plan is commensurate with the findings of the investigation and risk assessment. Indicate whether individuals responsible for data integrity deviations remain able to influence CGMP-related or drug application data at your firm.
- Interim measures describing the actions you have taken or will take to protect patients and to ensure the quality of your drugs, such as notifying your customers, recalling product, conducting additional testing, adding lots to your stability programs to assure stability, drug application actions, and enhanced complaint monitoring.
- Long-term measures describing any remediation efforts and enhancements to procedures, processes, methods, controls, systems, management oversight, and human resources (e.g., training, staffing improvements) designed to ensure the integrity of your company's data.
- A commitment to have a qualified consultant conduct extensive annual audits, for at least two years, to assist in evaluating CAPA effectiveness after you have executed your data integrity remediation protocol.
- Inform FDA if you will be hiring a chief integrity officer who is fully empowered to receive anonymous complaints from employees reporting data integrity concerns and with the authority to ensure any potential breach is promptly investigated by independent quality assurance function, along with expertise from outside entities whenever needed.
- A status report for any of the above activities already underway or completed.
Drug Production Suspended
We acknowledge your commitment to suspend production of all (b)(4) OTC (b)(4) drug products for the U.S. market. In response to this letter, clarify whether you intend to resume manufacturing drugs for the U.S. market at this facility in the future.
If you plan to resume any manufacturing operations regulated under the FD&C Act, notify this office before resuming your drug manufacturing operations. You are responsible for resolving all deficiencies and systemic flaws to ensure your firm is capable of ongoing CGMP compliance. In your notification to the Agency, provide a summary of your remediations to demonstrate that you have appropriately completed all CAPAs.
Quality System
Significant findings in this letter demonstrate that your firm does not operate an effective quality system in accord with CGMP. In addition to the lack of effective management oversight of your production, laboratory operations, we found your quality unit is not enabled to exercise proper authority and has insufficiently implemented its responsibilities. Executive management should immediately and comprehensively assess your company's operations to ensure that your systems, processes, and products conform to FDA requirements.
CGMP Consultant Recommended
Based upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements if your firm intends to resume manufacturing drugs for the U.S. market. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm's compliance status with FDA.
Your use of a consultant does not relieve your firm's obligation to comply with CGMP. Your firm's executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.
Drug Recall
On December 18, 2025, FDA held a teleconference with you recommending you remove any batches of (b)(4) OTC (b)(4) drug products and (b)(4) from the U.S. market.
On December 30, 2025, you communicated your commitment to cease manufacturing and distribution of all drugs for U.S. market. You also agreed to voluntary recall all drugs in current distribution in U.S.
On (b)(4), you issued a voluntary recall of all (b)(4).
Conclusion
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.
FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on December 23, 2025.
Correct any violations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any violations.
Failure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at Wizcure Pharmaa Private Limited located at H-881, Phase III, RIICO Industrial Area Bhiwadi, Rajasthan, India, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).
This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.
Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3030304532 and ATTN: Rafael E. Arroyo.
Sincerely,
/S/ Francis Godwin, Director, Office of Manufacturing Quality, Office of Compliance, Center for Drug Evaluation and Research
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Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/wizcure-pharmaa-private-limited-726378-06242026
BLS: Daily Work and Leisure Habits of Men and Women
WASHINGTON, July 1 (TNSLrpt) -- The U.S. Department of Labor Bureau of Labor Statistics issued the following document on June 30, 2026, from Economics Daily:
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Daily work and leisure habits of men and women
On an average day, 75 percent of men and 87 percent of women spent some time doing household activities like housework, cooking, lawn care, or household management in 2025. Of those who participated, men spent an average of 2.1 hours on days they did household activities, while women spent 2.8 hours.
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Chart: Average hours per day for people who engaged in selected primary activities, ... Show Full Article WASHINGTON, July 1 (TNSLrpt) -- The U.S. Department of Labor Bureau of Labor Statistics issued the following document on June 30, 2026, from Economics Daily: * * * Daily work and leisure habits of men and women On an average day, 75 percent of men and 87 percent of women spent some time doing household activities like housework, cooking, lawn care, or household management in 2025. Of those who participated, men spent an average of 2.1 hours on days they did household activities, while women spent 2.8 hours. * * * Chart: Average hours per day for people who engaged in selected primary activities,2025 annual averages
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Men were more likely than women to spend time on work and work-related activities (46 percent compared to 37 percent). Among those who worked on an average day, men averaged 8.3 hours, while women averaged 7.6 hours.
Nearly everyone aged 15 and older (95 percent) engaged in daily leisure or sports activities, such as watching TV, socializing, or exercising on an average day. Men were slightly more likely to participate than women (96 percent versus 94 percent) and spent more time doing so, averaging 5.8 hours compared to women's 5.0 hours.
Around 19 percent of men and 25 percent of women spent time caring for and helping household members. Among those who provided care, men averaged 1.9 hours per day, while women averaged 2.5 hours.
These data are from the American Time Use Survey (https://www.bls.gov/tus/). For more information, see "American Time Use Survey -- 2025 Results (https://www.bls.gov/news.release/archives/atus_06252026.htm)." We also have more charts (https://www.bls.gov/charts/american-time-use/) on activities and time use.
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SUGGESTED CITATION
Bureau of Labor Statistics, U.S. Department of Labor, The Economics Daily, Daily work and leisure habits of men and women at https://www.bls.gov/opub/ted/2026/daily-work-and-leisure-habits-of-men-and-women.htm (visited June 30, 2026).
* * *
View original text plus charts and tables here: https://www.bls.gov/opub/ted/2026/daily-work-and-leisure-habits-of-men-and-women.htm
* * *
Daily work and leisure habits of men and women
On an average day, 75 percent of men and 87 percent of women spent some time doing household activities like housework, cooking, lawn care, or household management in 2025. Of those who participated, men spent an average of 2.1 hours on days they did household activities, while women spent 2.8 hours.
* * *
Chart: Average hours per day for people who engaged in selected primary activities, ... Show Full Article WASHINGTON, July 1 (TNSLrpt) -- The U.S. Department of Labor Bureau of Labor Statistics issued the following document on June 30, 2026, from Economics Daily: * * * Daily work and leisure habits of men and women On an average day, 75 percent of men and 87 percent of women spent some time doing household activities like housework, cooking, lawn care, or household management in 2025. Of those who participated, men spent an average of 2.1 hours on days they did household activities, while women spent 2.8 hours. * * * Chart: Average hours per day for people who engaged in selected primary activities,2025 annual averages
* * *
Men were more likely than women to spend time on work and work-related activities (46 percent compared to 37 percent). Among those who worked on an average day, men averaged 8.3 hours, while women averaged 7.6 hours.
Nearly everyone aged 15 and older (95 percent) engaged in daily leisure or sports activities, such as watching TV, socializing, or exercising on an average day. Men were slightly more likely to participate than women (96 percent versus 94 percent) and spent more time doing so, averaging 5.8 hours compared to women's 5.0 hours.
Around 19 percent of men and 25 percent of women spent time caring for and helping household members. Among those who provided care, men averaged 1.9 hours per day, while women averaged 2.5 hours.
These data are from the American Time Use Survey (https://www.bls.gov/tus/). For more information, see "American Time Use Survey -- 2025 Results (https://www.bls.gov/news.release/archives/atus_06252026.htm)." We also have more charts (https://www.bls.gov/charts/american-time-use/) on activities and time use.
* * *
SUGGESTED CITATION
Bureau of Labor Statistics, U.S. Department of Labor, The Economics Daily, Daily work and leisure habits of men and women at https://www.bls.gov/opub/ted/2026/daily-work-and-leisure-habits-of-men-and-women.htm (visited June 30, 2026).
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View original text plus charts and tables here: https://www.bls.gov/opub/ted/2026/daily-work-and-leisure-habits-of-men-and-women.htm
BLS Western Region Issues Report on Occupational Employment and Wages in Longview-Kelso May 2025
SAN FRANCISCO, California, July 1 (TNSLrpt) -- Occupational Employment and Wages in Longview-Kelso May 2025 - A report from U.S. Department of Labor Bureau of Labor Statistics Western Region - June 30, 2026
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Workers in the Longview-Kelso, WA Metropolitan Statistical Area had an average (mean) hourly wage of $32.74 in May 2025, compared to the nationwide average of $33.54, the U.S. Bureau of Labor Statistics reported today. Regional Commissioner Chris Rosenlund noted that higher paying major occupational groups included management ($71.19), healthcare practitioners and technical ($57.49), ... Show Full Article SAN FRANCISCO, California, July 1 (TNSLrpt) -- Occupational Employment and Wages in Longview-Kelso May 2025 - A report from U.S. Department of Labor Bureau of Labor Statistics Western Region - June 30, 2026 * * * Workers in the Longview-Kelso, WA Metropolitan Statistical Area had an average (mean) hourly wage of $32.74 in May 2025, compared to the nationwide average of $33.54, the U.S. Bureau of Labor Statistics reported today. Regional Commissioner Chris Rosenlund noted that higher paying major occupational groups included management ($71.19), healthcare practitioners and technical ($57.49),and legal ($57.38). Lower paying occupations included food preparation and serving related ($21.20), building and grounds cleaning and maintenance ($22.17), and personal care and service ($22.29). (See table A.)
Occupational groups with the highest employment shares in the Longview area included office and administrative support (11.1 percent), production (10.6 percent), and transportation and material moving (10.4 percent). Major occupational groups on the lower end of local employment included legal (0.4 percent); arts, design, entertainment, sports, and media (0.8 percent); and life, physical, and social science (0.9 percent).
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Table A. Occupational employment and wages by major occupational group, United States and the Longview metropolitan area, May 2025
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One occupational group--production--was chosen to illustrate the diversity of data available for any of the 22 major occupational categories. Longview had 4,360 jobs in production, accounting for 10.6 percent of local area employment, compared to the 5.5-percent share nationally. The average hourly wage for this occupational group locally was $29.01, compared to the national wage of $24.81.
Some of the larger detailed occupations within the production group included paper goods machine setters, operators, and tenders (590), packaging and filling machine operators and tenders (540), and first-line supervisors of production and operating workers (440). Among the higher paying jobs in this group were power plant operators ($46.87) and first-line supervisors of production and operating workers ($43.16). At the lower end of the wage scale were food batchmakers ($19.65) and bakers ($21.21). (Detailed data for the production occupations are presented in table 1; for a complete listing of detailed occupations available go to https://data.bls.gov/oes/#/area/0031020/2025.)
Location quotients allow us to explore the occupational make-up of a metropolitan area by comparing the composition of jobs in an area relative to the national average. (See table 1.) For example, a location quotient of 2.00 indicates that an occupation accounts for twice the share of employment in the area than it does nationally. In the Longview area, above-average concentrations of employment were found in many of the occupations within the production group. For instance, paper goods machine setters, operators, and tenders were employed at 23.41 times the national rate in Longview, and wood sawing machine setters, operators, and tenders, at 16.76 times the U.S. average. Welders, cutters, solderers, and brazers had a location quotient of 1.09 in Longview, indicating that this particular occupation's local and national employment shares were similar.
The statistics in this release are from the Occupational Employment and Wage Statistics (OEWS) survey, a cooperative effort between BLS and the State Workforce Agencies (SWAs). BLS funds the survey and provides the procedures and technical support. State Workforce Agencies collect most of the data: in this case, the Washington Employment Security Department.
* * *
Federal Government Shutdown
Because of the lapse in federal appropriations from October 1 through November 12, 2025, additional collection and processing time were required for the May 2025 OEWS survey panel once appropriations resumed. The response rate for the May 2025 survey panel was within the normal range and no additional modifications to the OEWS methodology and procedures were necessary as a result of the shutdown.
* * *
Technical Note
The Occupational Employment and Wage Statistics (OEWS) survey is a semiannual survey measuring occupational employment and wage rates for wage and salary workers in nonfarm establishments in the United States. The OEWS data available from BLS include cross-industry occupational employment and wage estimates for the nation; over 530 areas, including states and the District of Columbia, metropolitan statistical areas (MSAs), nonmetropolitan areas, and territories; national industry-specific estimates at the NAICS sector, 3-digit, most 4-digit, and selected 5- and 6-digit industry levels; and national estimates by ownership across all industries and for schools and hospitals. Full OEWS data tables (https://www.bls.gov/oes/tables.htm) are available online.
Additional information about the OEWS estimates and methodology is available in the national Technical Notes (https://www.bls.gov/oes/2025/may/oes_tec.htm). The overall national response rate for the six panels, based on the 50 states and the District of Columbia, is 66.2 percent based on establishments and 67.2 percent based on weighted sampled employment. Sample sizes and response rates by metropolitan and nonmetropolitan area are available on the Additional OEWS data sets (https://www.bls.gov/oes/additional.htm) page.
Metropolitan area definitions
The substate area data published in this release reflect the standards and definitions established by the U.S. Office of Management and Budget.
The Longview-Kelso, WA Metropolitan Statistical Area includes Cowlitz County.
For more information
Answers to frequently asked questions (https://www.bls.gov/oes/oes_ques.htm) about the OEWS data, as well as general program documentation (https://www.bls.gov/oes/oes_doc.htm), are available on the OEWS website (https://www.bls.gov/oes/).
If you are deaf, hard of hearing, or have a speech disability, please dial 7-1-1 to access telecommunications relay services.
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Table 1. Employment and wage data for production occupations, Longview metropolitan area, May 2025
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View original text plus charts and tables here: https://www.bls.gov/regions/west/news-release/2026/occupationalemploymentandwages_longview_20260630.htm
* * *
Workers in the Longview-Kelso, WA Metropolitan Statistical Area had an average (mean) hourly wage of $32.74 in May 2025, compared to the nationwide average of $33.54, the U.S. Bureau of Labor Statistics reported today. Regional Commissioner Chris Rosenlund noted that higher paying major occupational groups included management ($71.19), healthcare practitioners and technical ($57.49), ... Show Full Article SAN FRANCISCO, California, July 1 (TNSLrpt) -- Occupational Employment and Wages in Longview-Kelso May 2025 - A report from U.S. Department of Labor Bureau of Labor Statistics Western Region - June 30, 2026 * * * Workers in the Longview-Kelso, WA Metropolitan Statistical Area had an average (mean) hourly wage of $32.74 in May 2025, compared to the nationwide average of $33.54, the U.S. Bureau of Labor Statistics reported today. Regional Commissioner Chris Rosenlund noted that higher paying major occupational groups included management ($71.19), healthcare practitioners and technical ($57.49),and legal ($57.38). Lower paying occupations included food preparation and serving related ($21.20), building and grounds cleaning and maintenance ($22.17), and personal care and service ($22.29). (See table A.)
Occupational groups with the highest employment shares in the Longview area included office and administrative support (11.1 percent), production (10.6 percent), and transportation and material moving (10.4 percent). Major occupational groups on the lower end of local employment included legal (0.4 percent); arts, design, entertainment, sports, and media (0.8 percent); and life, physical, and social science (0.9 percent).
* * *
Table A. Occupational employment and wages by major occupational group, United States and the Longview metropolitan area, May 2025
* * *
One occupational group--production--was chosen to illustrate the diversity of data available for any of the 22 major occupational categories. Longview had 4,360 jobs in production, accounting for 10.6 percent of local area employment, compared to the 5.5-percent share nationally. The average hourly wage for this occupational group locally was $29.01, compared to the national wage of $24.81.
Some of the larger detailed occupations within the production group included paper goods machine setters, operators, and tenders (590), packaging and filling machine operators and tenders (540), and first-line supervisors of production and operating workers (440). Among the higher paying jobs in this group were power plant operators ($46.87) and first-line supervisors of production and operating workers ($43.16). At the lower end of the wage scale were food batchmakers ($19.65) and bakers ($21.21). (Detailed data for the production occupations are presented in table 1; for a complete listing of detailed occupations available go to https://data.bls.gov/oes/#/area/0031020/2025.)
Location quotients allow us to explore the occupational make-up of a metropolitan area by comparing the composition of jobs in an area relative to the national average. (See table 1.) For example, a location quotient of 2.00 indicates that an occupation accounts for twice the share of employment in the area than it does nationally. In the Longview area, above-average concentrations of employment were found in many of the occupations within the production group. For instance, paper goods machine setters, operators, and tenders were employed at 23.41 times the national rate in Longview, and wood sawing machine setters, operators, and tenders, at 16.76 times the U.S. average. Welders, cutters, solderers, and brazers had a location quotient of 1.09 in Longview, indicating that this particular occupation's local and national employment shares were similar.
The statistics in this release are from the Occupational Employment and Wage Statistics (OEWS) survey, a cooperative effort between BLS and the State Workforce Agencies (SWAs). BLS funds the survey and provides the procedures and technical support. State Workforce Agencies collect most of the data: in this case, the Washington Employment Security Department.
* * *
Federal Government Shutdown
Because of the lapse in federal appropriations from October 1 through November 12, 2025, additional collection and processing time were required for the May 2025 OEWS survey panel once appropriations resumed. The response rate for the May 2025 survey panel was within the normal range and no additional modifications to the OEWS methodology and procedures were necessary as a result of the shutdown.
* * *
Technical Note
The Occupational Employment and Wage Statistics (OEWS) survey is a semiannual survey measuring occupational employment and wage rates for wage and salary workers in nonfarm establishments in the United States. The OEWS data available from BLS include cross-industry occupational employment and wage estimates for the nation; over 530 areas, including states and the District of Columbia, metropolitan statistical areas (MSAs), nonmetropolitan areas, and territories; national industry-specific estimates at the NAICS sector, 3-digit, most 4-digit, and selected 5- and 6-digit industry levels; and national estimates by ownership across all industries and for schools and hospitals. Full OEWS data tables (https://www.bls.gov/oes/tables.htm) are available online.
Additional information about the OEWS estimates and methodology is available in the national Technical Notes (https://www.bls.gov/oes/2025/may/oes_tec.htm). The overall national response rate for the six panels, based on the 50 states and the District of Columbia, is 66.2 percent based on establishments and 67.2 percent based on weighted sampled employment. Sample sizes and response rates by metropolitan and nonmetropolitan area are available on the Additional OEWS data sets (https://www.bls.gov/oes/additional.htm) page.
Metropolitan area definitions
The substate area data published in this release reflect the standards and definitions established by the U.S. Office of Management and Budget.
The Longview-Kelso, WA Metropolitan Statistical Area includes Cowlitz County.
For more information
Answers to frequently asked questions (https://www.bls.gov/oes/oes_ques.htm) about the OEWS data, as well as general program documentation (https://www.bls.gov/oes/oes_doc.htm), are available on the OEWS website (https://www.bls.gov/oes/).
If you are deaf, hard of hearing, or have a speech disability, please dial 7-1-1 to access telecommunications relay services.
* * *
Table 1. Employment and wage data for production occupations, Longview metropolitan area, May 2025
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View original text plus charts and tables here: https://www.bls.gov/regions/west/news-release/2026/occupationalemploymentandwages_longview_20260630.htm
BLS Western Region Issues Report on Occupational Employment and Wages in Bremerton-Silverdale-Port Orchard May 2025
SAN FRANCISCO, California, July 1 (TNSLrpt) -- Occupational Employment and Wages in Bremerton-Silverdale-Port Orchard May 2025 - A report from U.S. Department of Labor Bureau of Labor Statistics Western Region - June 30, 2026
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Workers in the Bremerton-Silverdale-Port Orchard, WA Metropolitan Statistical Area had an average (mean) hourly wage of $37.03 in May 2025, compared to the nationwide average of $33.54, the U.S. Bureau of Labor Statistics reported today. Regional Commissioner Chris Rosenlund noted that higher paying major occupational groups included management ($75.41), healthcare ... Show Full Article SAN FRANCISCO, California, July 1 (TNSLrpt) -- Occupational Employment and Wages in Bremerton-Silverdale-Port Orchard May 2025 - A report from U.S. Department of Labor Bureau of Labor Statistics Western Region - June 30, 2026 * * * Workers in the Bremerton-Silverdale-Port Orchard, WA Metropolitan Statistical Area had an average (mean) hourly wage of $37.03 in May 2025, compared to the nationwide average of $33.54, the U.S. Bureau of Labor Statistics reported today. Regional Commissioner Chris Rosenlund noted that higher paying major occupational groups included management ($75.41), healthcarepractitioners and technical ($58.11), and computer and mathematical ($55.88). Lower paying occupations included food preparation and serving related ($22.80), building and grounds cleaning and maintenance ($22.93), and healthcare support ($24.53). (See table A.)
Occupational groups with the highest employment shares in the Bremerton area included food preparation and serving related (9.8 percent), office and administrative support (9.7 percent), and sales and related (8.0 percent). Major occupational groups on the lower end of local employment included legal (0.5 percent); arts, design, entertainment, sports, and media (0.9 percent); and life, physical, and social science (1.6 percent).
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Table A. Occupational employment and wages by major occupational group, United States and the Bremerton metropolitan area, May 2025
* * *
One occupational group--construction and extraction--was chosen to illustrate the diversity of data available for any of the 22 major occupational categories. Bremerton had 6,860 jobs in construction and extraction, accounting for 7.3 percent of local area employment, compared to the 4.1-percent share nationally. The average hourly wage for this occupational group locally was $38.23, compared to the national wage of $31.42.
Some of the larger detailed occupations within the construction and extraction group included electricians (1,100), plumbers, pipefitters, and steamfitters (1,040), and carpenters (940). Among the higher paying jobs in this group were first-line supervisors of construction trades and extraction workers ($53.77) and construction and building inspectors ($46.24). At the lower end of the wage scale were construction laborers ($28.67) and roofers ($31.56). (Detailed data for the construction and extraction occupations are presented in table 1; for a complete listing of detailed occupations available go to https://data.bls.gov/oes/#/area/0014740/2025.)
Location quotients allow us to explore the occupational make-up of a metropolitan area by comparing the composition of jobs in an area relative to the national average. (See table 1.) For example, a location quotient of 2.00 indicates that an occupation accounts for twice the share of employment in the area than it does nationally. In the Bremerton area, above-average concentrations of employment were found in many of the occupations within the construction and extraction group. For instance, painters, construction and maintenance were employed at 5.94 times the national rate in Bremerton, and plumbers, pipefitters, and steamfitters, at 3.72 times the U.S. average. Construction laborers had a location quotient of 0.94 in Bremerton, indicating that this particular occupation's local and national employment shares were similar.
The statistics in this release are from the Occupational Employment and Wage Statistics (OEWS) survey, a cooperative effort between BLS and the State Workforce Agencies (SWAs). BLS funds the survey and provides the procedures and technical support. State Workforce Agencies collect most of the data: in this case, the Washington Employment Security Department.
* * *
Federal Government Shutdown
Because of the lapse in federal appropriations from October 1 through November 12, 2025, additional collection and processing time were required for the May 2025 OEWS survey panel once appropriations resumed. The response rate for the May 2025 survey panel was within the normal range and no additional modifications to the OEWS methodology and procedures were necessary as a result of the shutdown.
* * *
Technical Note
The Occupational Employment and Wage Statistics (OEWS) survey is a semiannual survey measuring occupational employment and wage rates for wage and salary workers in nonfarm establishments in the United States. The OEWS data available from BLS include cross-industry occupational employment and wage estimates for the nation; over 530 areas, including states and the District of Columbia, metropolitan statistical areas (MSAs), nonmetropolitan areas, and territories; national industry-specific estimates at the NAICS sector, 3-digit, most 4-digit, and selected 5- and 6-digit industry levels; and national estimates by ownership across all industries and for schools and hospitals. Full OEWS data tables (https://www.bls.gov/oes/tables.htm) are available online.
Additional information about the OEWS estimates and methodology is available in the national Technical Notes (https://www.bls.gov/oes/2025/may/oes_tec.htm). The overall national response rate for the six panels, based on the 50 states and the District of Columbia, is 66.2 percent based on establishments and 67.2 percent based on weighted sampled employment. Sample sizes and response rates by metropolitan and nonmetropolitan area are available on the Additional OEWS data sets (https://www.bls.gov/oes/additional.htm) page.
Metropolitan area definitions
The substate area data published in this release reflect the standards and definitions established by the U.S. Office of Management and Budget.
The Bremerton-Silverdale-Port Orchard, WA Metropolitan Statistical Area includes Kitsap County.
For more information
Answers to frequently asked questions (https://www.bls.gov/oes/oes_ques.htm) about the OEWS data, as well as general program documentation (https://www.bls.gov/oes/oes_doc.htm), are available on the OEWS website (https://www.bls.gov/oes/).
If you are deaf, hard of hearing, or have a speech disability, please dial 7-1-1 to access telecommunications relay services.
* * *
Table 1. Employment and wage data for construction and extraction occupations, Bremerton metropolitan area, May 2025
* * *
View original text plus charts and tables here: https://www.bls.gov/regions/west/news-release/2026/occupationalemploymentandwages_bremerton_20260630.htm
* * *
Workers in the Bremerton-Silverdale-Port Orchard, WA Metropolitan Statistical Area had an average (mean) hourly wage of $37.03 in May 2025, compared to the nationwide average of $33.54, the U.S. Bureau of Labor Statistics reported today. Regional Commissioner Chris Rosenlund noted that higher paying major occupational groups included management ($75.41), healthcare ... Show Full Article SAN FRANCISCO, California, July 1 (TNSLrpt) -- Occupational Employment and Wages in Bremerton-Silverdale-Port Orchard May 2025 - A report from U.S. Department of Labor Bureau of Labor Statistics Western Region - June 30, 2026 * * * Workers in the Bremerton-Silverdale-Port Orchard, WA Metropolitan Statistical Area had an average (mean) hourly wage of $37.03 in May 2025, compared to the nationwide average of $33.54, the U.S. Bureau of Labor Statistics reported today. Regional Commissioner Chris Rosenlund noted that higher paying major occupational groups included management ($75.41), healthcarepractitioners and technical ($58.11), and computer and mathematical ($55.88). Lower paying occupations included food preparation and serving related ($22.80), building and grounds cleaning and maintenance ($22.93), and healthcare support ($24.53). (See table A.)
Occupational groups with the highest employment shares in the Bremerton area included food preparation and serving related (9.8 percent), office and administrative support (9.7 percent), and sales and related (8.0 percent). Major occupational groups on the lower end of local employment included legal (0.5 percent); arts, design, entertainment, sports, and media (0.9 percent); and life, physical, and social science (1.6 percent).
* * *
Table A. Occupational employment and wages by major occupational group, United States and the Bremerton metropolitan area, May 2025
* * *
One occupational group--construction and extraction--was chosen to illustrate the diversity of data available for any of the 22 major occupational categories. Bremerton had 6,860 jobs in construction and extraction, accounting for 7.3 percent of local area employment, compared to the 4.1-percent share nationally. The average hourly wage for this occupational group locally was $38.23, compared to the national wage of $31.42.
Some of the larger detailed occupations within the construction and extraction group included electricians (1,100), plumbers, pipefitters, and steamfitters (1,040), and carpenters (940). Among the higher paying jobs in this group were first-line supervisors of construction trades and extraction workers ($53.77) and construction and building inspectors ($46.24). At the lower end of the wage scale were construction laborers ($28.67) and roofers ($31.56). (Detailed data for the construction and extraction occupations are presented in table 1; for a complete listing of detailed occupations available go to https://data.bls.gov/oes/#/area/0014740/2025.)
Location quotients allow us to explore the occupational make-up of a metropolitan area by comparing the composition of jobs in an area relative to the national average. (See table 1.) For example, a location quotient of 2.00 indicates that an occupation accounts for twice the share of employment in the area than it does nationally. In the Bremerton area, above-average concentrations of employment were found in many of the occupations within the construction and extraction group. For instance, painters, construction and maintenance were employed at 5.94 times the national rate in Bremerton, and plumbers, pipefitters, and steamfitters, at 3.72 times the U.S. average. Construction laborers had a location quotient of 0.94 in Bremerton, indicating that this particular occupation's local and national employment shares were similar.
The statistics in this release are from the Occupational Employment and Wage Statistics (OEWS) survey, a cooperative effort between BLS and the State Workforce Agencies (SWAs). BLS funds the survey and provides the procedures and technical support. State Workforce Agencies collect most of the data: in this case, the Washington Employment Security Department.
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Federal Government Shutdown
Because of the lapse in federal appropriations from October 1 through November 12, 2025, additional collection and processing time were required for the May 2025 OEWS survey panel once appropriations resumed. The response rate for the May 2025 survey panel was within the normal range and no additional modifications to the OEWS methodology and procedures were necessary as a result of the shutdown.
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Technical Note
The Occupational Employment and Wage Statistics (OEWS) survey is a semiannual survey measuring occupational employment and wage rates for wage and salary workers in nonfarm establishments in the United States. The OEWS data available from BLS include cross-industry occupational employment and wage estimates for the nation; over 530 areas, including states and the District of Columbia, metropolitan statistical areas (MSAs), nonmetropolitan areas, and territories; national industry-specific estimates at the NAICS sector, 3-digit, most 4-digit, and selected 5- and 6-digit industry levels; and national estimates by ownership across all industries and for schools and hospitals. Full OEWS data tables (https://www.bls.gov/oes/tables.htm) are available online.
Additional information about the OEWS estimates and methodology is available in the national Technical Notes (https://www.bls.gov/oes/2025/may/oes_tec.htm). The overall national response rate for the six panels, based on the 50 states and the District of Columbia, is 66.2 percent based on establishments and 67.2 percent based on weighted sampled employment. Sample sizes and response rates by metropolitan and nonmetropolitan area are available on the Additional OEWS data sets (https://www.bls.gov/oes/additional.htm) page.
Metropolitan area definitions
The substate area data published in this release reflect the standards and definitions established by the U.S. Office of Management and Budget.
The Bremerton-Silverdale-Port Orchard, WA Metropolitan Statistical Area includes Kitsap County.
For more information
Answers to frequently asked questions (https://www.bls.gov/oes/oes_ques.htm) about the OEWS data, as well as general program documentation (https://www.bls.gov/oes/oes_doc.htm), are available on the OEWS website (https://www.bls.gov/oes/).
If you are deaf, hard of hearing, or have a speech disability, please dial 7-1-1 to access telecommunications relay services.
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Table 1. Employment and wage data for construction and extraction occupations, Bremerton metropolitan area, May 2025
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View original text plus charts and tables here: https://www.bls.gov/regions/west/news-release/2026/occupationalemploymentandwages_bremerton_20260630.htm
AFIMSC Convenes Task Force Focused on Kadena Infrastructure
JOINT BASE SAN ANTONIO, Texas, July 1 -- The U.S. Air Force Installation and Mission Support Center issued the following news on June 30, 2026:
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AFIMSC convenes task force focused on Kadena infrastructure
Approximately 50 subject matter experts across Air Force Installation Mission Support Center and the Air Force gathered here June 8-12 to find solutions to challenges affecting military housing and infrastructure at Kadena Air Base, Japan.
It was the first phase of meetings for the Okinawa Infrastructure Operational Planning Team to identify requirements needed to ensure the installation ... Show Full Article JOINT BASE SAN ANTONIO, Texas, July 1 -- The U.S. Air Force Installation and Mission Support Center issued the following news on June 30, 2026: * * * AFIMSC convenes task force focused on Kadena infrastructure Approximately 50 subject matter experts across Air Force Installation Mission Support Center and the Air Force gathered here June 8-12 to find solutions to challenges affecting military housing and infrastructure at Kadena Air Base, Japan. It was the first phase of meetings for the Okinawa Infrastructure Operational Planning Team to identify requirements needed to ensure the installationmaintains its status as a power projection platform.
The base has been plagued by deteriorating facility conditions such as corrosion, rust and separation of concrete for nearly two decades. Constrained resources, environment and a high humidity climate as some of the issues that have strained efforts to maintain homes, hangars and other infrastructure.
The team found hundreds of instances where corrosion and rust impacted aging infrastructure including a munitions storage facility, and a chapel. In some instances, the buildings have been condemned due to the safety risks they pose.
"Kadena is one of the most corrosive environments in the world, and getting this team together to fix a problem that keeps getting worse drove the urgency of this meeting," said Col. Justin Morrison, Detachment 2 commander.
Pacific Air Forces leaders cited a constrained resource environment and a high humidity climate as some of the issues that have strained efforts to maintain homes and hangars and other infrastructure at the air base.
Tackling phase one of the project required the OPT to prioritize requirements into three lines of effort examining infrastructure, military, family housing, and execution and contracting.
"Our goal was to identify a list of requirements to improve the base infrastructure, but the challenge was figuring out which was the most critical," said Maj. Alexander Wright, PACAF Civil Engineering, who traveled here from Joint Base Pearl Harbor-Hickam, Hawaii.
Wright and his team sifted through an estimated 4,500 different requirements looking at facility conditions and many other factors to prioritize requirements.
"Everyone brought creative ideas," said Lt. Col. L.J. Harris, Fifth Air Force. "We went through a full analysis, highlighting all the different things and talked about what's within our span of control to change and what's not and analyzed the whole picture to understanding the environment in Okinawa and all the challenges - and we're getting after those challenges."
After one week and many long hours working side by side in a unique opportunity, leaders walked away with a structure for three different courses of action and feedback from AFIMSC leadership.
Leaders are expected to present three recommendations to senior leaders later this month before an investment plan is approved.
"It sends out the fact that AFIMSC and the Air Force at large is serious about getting after this problem and coming up with solutions to help make housing safe and suitable for residents and ensuring Kadena's infrastructure is recapitalized to deter today and tomorrow's threats," Morrison said.
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Original text here: https://www.afimsc.af.mil/News/Article-Display/Article/4530537/afimsc-convenes-task-force-focused-on-kadena-infrastructure/
* * *
AFIMSC convenes task force focused on Kadena infrastructure
Approximately 50 subject matter experts across Air Force Installation Mission Support Center and the Air Force gathered here June 8-12 to find solutions to challenges affecting military housing and infrastructure at Kadena Air Base, Japan.
It was the first phase of meetings for the Okinawa Infrastructure Operational Planning Team to identify requirements needed to ensure the installation ... Show Full Article JOINT BASE SAN ANTONIO, Texas, July 1 -- The U.S. Air Force Installation and Mission Support Center issued the following news on June 30, 2026: * * * AFIMSC convenes task force focused on Kadena infrastructure Approximately 50 subject matter experts across Air Force Installation Mission Support Center and the Air Force gathered here June 8-12 to find solutions to challenges affecting military housing and infrastructure at Kadena Air Base, Japan. It was the first phase of meetings for the Okinawa Infrastructure Operational Planning Team to identify requirements needed to ensure the installationmaintains its status as a power projection platform.
The base has been plagued by deteriorating facility conditions such as corrosion, rust and separation of concrete for nearly two decades. Constrained resources, environment and a high humidity climate as some of the issues that have strained efforts to maintain homes, hangars and other infrastructure.
The team found hundreds of instances where corrosion and rust impacted aging infrastructure including a munitions storage facility, and a chapel. In some instances, the buildings have been condemned due to the safety risks they pose.
"Kadena is one of the most corrosive environments in the world, and getting this team together to fix a problem that keeps getting worse drove the urgency of this meeting," said Col. Justin Morrison, Detachment 2 commander.
Pacific Air Forces leaders cited a constrained resource environment and a high humidity climate as some of the issues that have strained efforts to maintain homes and hangars and other infrastructure at the air base.
Tackling phase one of the project required the OPT to prioritize requirements into three lines of effort examining infrastructure, military, family housing, and execution and contracting.
"Our goal was to identify a list of requirements to improve the base infrastructure, but the challenge was figuring out which was the most critical," said Maj. Alexander Wright, PACAF Civil Engineering, who traveled here from Joint Base Pearl Harbor-Hickam, Hawaii.
Wright and his team sifted through an estimated 4,500 different requirements looking at facility conditions and many other factors to prioritize requirements.
"Everyone brought creative ideas," said Lt. Col. L.J. Harris, Fifth Air Force. "We went through a full analysis, highlighting all the different things and talked about what's within our span of control to change and what's not and analyzed the whole picture to understanding the environment in Okinawa and all the challenges - and we're getting after those challenges."
After one week and many long hours working side by side in a unique opportunity, leaders walked away with a structure for three different courses of action and feedback from AFIMSC leadership.
Leaders are expected to present three recommendations to senior leaders later this month before an investment plan is approved.
"It sends out the fact that AFIMSC and the Air Force at large is serious about getting after this problem and coming up with solutions to help make housing safe and suitable for residents and ensuring Kadena's infrastructure is recapitalized to deter today and tomorrow's threats," Morrison said.
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Original text here: https://www.afimsc.af.mil/News/Article-Display/Article/4530537/afimsc-convenes-task-force-focused-on-kadena-infrastructure/