Federal Executive Branch
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Smithsonian Institution National Museum of the American Indian: Native Art Market Brings Indigenous Artisans to Washington for Curated Shopping Experience
WASHINGTON, Nov. 26 -- The Smithsonian Institution National Museum of the American Indian issued the following news release on Nov. 25, 2025:* * *
Native Art Market Brings Indigenous Artisans to Washington for Curated Shopping Experience
The Smithsonian's National Museum of the American Indian's Native Art Market returns to the museum in Washington, D.C., Dec. 6 and 7, from 10 a.m. to 5 p.m. This annual event features award-winning and innovative Indigenous artists from across the Western Hemisphere. Visitors can meet Indigenous artists and learn about traditional Native arts and contemporary ... Show Full Article WASHINGTON, Nov. 26 -- The Smithsonian Institution National Museum of the American Indian issued the following news release on Nov. 25, 2025: * * * Native Art Market Brings Indigenous Artisans to Washington for Curated Shopping Experience The Smithsonian's National Museum of the American Indian's Native Art Market returns to the museum in Washington, D.C., Dec. 6 and 7, from 10 a.m. to 5 p.m. This annual event features award-winning and innovative Indigenous artists from across the Western Hemisphere. Visitors can meet Indigenous artists and learn about traditional Native arts and contemporaryNative creativity. Artists will offer authentic, hand-crafted works of art, including jewelry, fashion, photography and pottery. Serious collectors and casual shoppers will find one-of-a-kind pieces at a wide range of prices.
The list of artists currently scheduled to attend is:
Basketry
* Carrie Hill (Akwesasne Mohawk)
* Holly Pyke (Saint Regis Mohawk)
Beadwork
* Beth Bush (Potawatomi/Odawa)
* Cyndy Milda (Shakopee Mdewakanton Sioux Community)
* Tessa Robledo (Comanche/Kiowa)
* Naomi Smith (Chippewas of Nawash)
Dolls
* Jhane Myers (Comanche/Blackfeet)
Graphic Arts
* Peter Boome (Upper Skagit)
Jewelry
* Vina Brown (Heiltsuk)
* Brenda Boyd (Dine [Navajo])
* Robert Johnson (Dine [Navajo])
* Steve LaRance (Hopi) and Marian Denipah-LaRance (Ohkay Owingeh)
* Christie Latone (A:shiwi [Zuni])
* Gerren Peters (Scowlitz)
* Tanya June Rafael (Dine [Navajo])
* Janalee Reano Valencia (San Felipe Pueblo)
* Charlene Sanchez Reano (San Felipe Pueblo)
* Shaax' Saani and Naats Tla'a (Tlingit)
* Marvin Slim (Dine [Navajo])
* Travis Snyder (Eastern Shoshone)
Leatherwork
* Osceola Red Shirt (Oglala Lakota)
Painting
* Brent Learned (Cheyenne and Arapaho Tribes)
Photography
* Eugene Tapahe (Dine [Navajo])
Pottery
* Luis Enrique Gutierrez (Nicoya)
* Madeline Naranjo (Santa Clara Pueblo)
* Dow Redcorn (Osage Nation)
* Kathleen Wall (Jemez Pueblo/White Earth)
Sculpture and Carvings
* Sam Dimmick (Alaska Eskimo)
Textiles and Attire
* Ciprian Herminio Fernandez Quispe (Quechuas)
* Penny Singer (Dine [Navajo])
During breaks from shopping at Native Art Market, visitors can enjoy curator-led tours of three of the museum's exhibitions, including its newest, "Water's Edge: The Art of Truman Lowe." Tours will be at 11:30 a.m. and 1:30 and 2:30 p.m. Dec. 6 and 7. Also on Dec. 7, the museum will offer a tour of the National Native American Veterans Memorial at 3:30 p.m. in commemoration of Pearl Harbor Day. This schedule is subject to change; check the website for updates.
Young visitors can enjoy a make-and-take winter craft in the imagiNATIONS Activity Center located on the museum's third floor.
The museum's espresso bar will offer a special winter menu for both days of the art market. Must-try items include warm hibiscus juniper-spiced cider; champurrado, a traditional Mexican hot chocolate drink made with masa harina, and notes of cinnamon, nutmeg and piloncillo; and pinon, which are Mexican wedding cookies made with pine nuts.
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About the Museum
In partnership with Native peoples and their allies, the National Museum of the American Indian fosters a richer shared human experience through a more informed understanding of Native peoples. Through two locations, it features exhibitions and programs in New York City and the National Mall in Washington, D.C. For additional information, including hours and directions, visit AmericanIndian.si.edu. Follow the museum via social media @SmithsonianNMAI.
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Original text here: https://www.si.edu/newsdesk/releases/native-art-market-brings-indigenous-artisans-washington-curated-shopping-0
President Trump Issues Proclamation on Thanksgiving Day, 2025
WASHINGTON, Nov. 26 -- President Trump issued the following proclamation on Nov. 25, 2025:* * *
Thanksgiving Day, 2025
In 1789, just years after America's triumph over tyranny in the Revolutionary War, President George Washington established the first National Day of Thanksgiving, declaring "the duty of all Nations to acknowledge the providence of Almighty God, to obey His will, to be grateful for His benefits, and humbly to implore His protection and favor." Decades later, in the midst of the bloody Civil War, President Abraham Lincoln implored the Nation to join in unity for "a day of Thanksgiving ... Show Full Article WASHINGTON, Nov. 26 -- President Trump issued the following proclamation on Nov. 25, 2025: * * * Thanksgiving Day, 2025 In 1789, just years after America's triumph over tyranny in the Revolutionary War, President George Washington established the first National Day of Thanksgiving, declaring "the duty of all Nations to acknowledge the providence of Almighty God, to obey His will, to be grateful for His benefits, and humbly to implore His protection and favor." Decades later, in the midst of the bloody Civil War, President Abraham Lincoln implored the Nation to join in unity for "a day of Thanksgivingand Praise to our beneficent Father who dwelleth in the Heavens." In every generation since, this spirit of reverence, trust, and gratitude has preserved our way of life and made America the strongest, greatest, and most resilient Nation the world has ever known.
From the pilgrims who settled our continent and the patriots who won our independence on the battlefield to the pioneers who tamed the west and the warriors who have preserved our freedom in distant lands, the spirit of gratitude and grit embodied by those who celebrated the first Thanksgiving more than 400 years ago have stood at the very heart of what it means to be an American.
This year, God has bestowed abundant blessings all across our land and indeed the entire world. As we give thanks to Him, we continue to advance our Nation through strong leadership and commonsense policy. As a result, the American economy is roaring back, we are making progress on lowering the cost of living, a new era of peace is sweeping around the world, our sovereignty is being swiftly restored, and the American spirit is coming back greater and more powerful than ever before.
As we prepare to celebrate 250 glorious years of American independence, this Thanksgiving, we summon the faith, resolve, and unflinching fortitude of the giants of American history who came before us. We vow to build a future that echoes their sacrifice. Above all, we offer our endless gratitude to Almighty God for His love, grace, and infinite blessings.
NOW, THEREFORE, I, DONALD J. TRUMP, President of the United States of America, by virtue of the authority vested in me by the Constitution and the laws of the United States, do hereby proclaim Thursday, November 27, 2025, as a National Day of Thanksgiving. I encourage all Americans to gather, in homes and places of worship, to offer a prayer of thanks to God for our many blessings.
IN WITNESS WHEREOF, I have hereunto set my hand this twenty-fifth day of November, in the year of our Lord two thousand twenty-five, and of the Independence of the United States of America the two hundred and fiftieth.
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Original text here: https://www.whitehouse.gov/presidential-actions/2025/11/thanksgiving-day-2025/
HUD Announces Crime Hotline to Keep Americans Safe in HUD-Funded Housing
WASHINGTON, Nov. 26 -- The Department of Housing and Urban Development issued the following news release:* * *
HUD Announces Crime Hotline to Keep Americans Safe in HUD-Funded Housing
Hotline will address crime in real time, builds on commitment to uphold President Trump's Executive Orders
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MEMPHIS, Tenn. - Housing and Urban Development (HUD) Secretary Scott Turner announced a hotline for Americans to report crime tips and criminal activity in HUD-funded housing. The hotline will help to rid HUD-funded housing of gang and drug activity, illegal aliens, sex offenders, human traffickers, fraudulent ... Show Full Article WASHINGTON, Nov. 26 -- The Department of Housing and Urban Development issued the following news release: * * * HUD Announces Crime Hotline to Keep Americans Safe in HUD-Funded Housing Hotline will address crime in real time, builds on commitment to uphold President Trump's Executive Orders * MEMPHIS, Tenn. - Housing and Urban Development (HUD) Secretary Scott Turner announced a hotline for Americans to report crime tips and criminal activity in HUD-funded housing. The hotline will help to rid HUD-funded housing of gang and drug activity, illegal aliens, sex offenders, human traffickers, fraudulentactivity, and other threatening individuals who seek to disturb and endanger American citizens in their homes. Reports of crime at HUD properties in Memphis and Washington D.C. will be prioritized, in alignment with HUD's work on the Memphis Safe Task Force and the D.C. Safe and Beautiful Task Force. The hotline is part of the broader cross-agency efforts to facilitate coordination between HUD, the U.S. Department of Justice (DOJ), the Federal Bureau of Investigation (FBI), and other partner agencies, as directed by President Trump's Executive Orders.
"Americans from the elderly to single-parent families with young children turn to HUD for housing assistance. No American who calls HUD housing home should feel that crime is an inevitable part of their living conditions. With today's hotline announcement, we are excited to welcome public input because there is no one who knows a community better than its residents. I thank Attorney General Bondi, Director Gady Serralta and the U.S. Marshals, Governor Lee, and Senators Blackburn and Hagerty for their commitment to make Memphis safe. We will continue to address crime and promote safety across our great nation because safer communities start with safer homes," said HUD Secretary Scott Turner.
"The Trump administration's initiative to Make Memphis Safe Again has saved lives, reunited kids with their families, and shown that American citizens do not have to tolerate rampant crime in their cities. I'm grateful to my dear friend Secretary Turner, our congressional and local partners, and all law enforcement agents for the incredible work we've done for an iconic American city," said Attorney General Pam Bondi.
"Since the first day we began the Memphis Safe Task Force we have heard from the residents that they are thankful we are here and making Memphis safer for them," said United States Marshal Director Gadyaces S. Serralta. "Now the residents themselves can help make their city safer by calling in tips and helping us in getting the people making Memphis unsafe off the streets. This is a win-win for everyone."
"The federal government should not be providing housing to illegal aliens, sex offenders, human traffickers, and other violent criminals," said U.S. Senator Marsha Blackburn (R-TN). "HUD's new hotline gives Americans with housing assistance a direct way to report crime and protect their homes, and I appreciate Secretary Turner prioritizing the safety of Memphians."
"I was pleased to be in Memphis yesterday getting updates on the progress of Operation Memphis Safe combating crime in Shelby County. I want to express my gratitude to the local officials and law enforcement for their incredible work," said U.S. Senator Bill Hagerty (R-TN). "Together, we will make Memphis the safest city in America."
The establishment of the crime hotline advances the work of the Memphis Safe Task Force, established by President Trump on September 15, 2025 to restore law and order in Memphis, Tennessee; the DC Safe and Beautiful Task Force, established by President Trump on March 28, 2025; and President Trump's Executive Order, Additional Measure to Address the Crime Emergency in the District of Columbia. The hotline will aid law enforcement in identifying individuals who threaten the safety of HUD-funded housing tenants by engaging in criminal activity including drug distribution, violent criminal activity, and domestic violence.
Since August 2025, the D.C. Safe and Beautiful Task Force has arrested more than 6,677 violent fugitives, including 16 for homicide, 1,056 for narcotics, 502 for weapons offenses, 29 for sex offenses, and 44 known gang members. Investigators also seized 634 illegally possessed firearms.
Since October 2025, the Memphis Safe Task Force arrested 3,151 violent fugitives, including 12 for homicide, 362 for narcotics, 260 for weapons offenses, 71 for sex offenses, and 327 known gang members. In addition, investigators seized 501 illegally possessed firearms.
The crime hotline will build on HUD's work to ensure taxpayer resources are prioritized for American citizens. This year, Secretary Turner:
* Signed the "American Housing Programs for American Citizens" MOU with DHS Secretary Kristi Noem to end the wasteful misappropriation of taxpayer dollars to benefit illegal aliens.
* Guaranteed that HUD-backed loans only go to American citizens through revised FHA residency requirements.
* Demanded citizenship status for all residents of HUD-funded housing.
To submit a tip to the crime hotline, individuals should call 1-800-347-3735. Reports may be submitted online at HUDOIG.gov/hotline.
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Original text here: https://www.hud.gov/news/hud-no-25-138
FDA Issues Warning Letter to Owen Biosciences
WASHINGTON, Nov. 26 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Owen Biosciences Inc. from the Center for Drug Evaluation and Research:* * *
Recipient: Dr. Donald R. Owen, Chief Executive Officer, Owen Biosciences, Inc., 7053 Revenue Drive, Baton Rouge, LA 70809-4918, United States
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
Dear Dr. Owen:
The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Owen Biosciences, Inc., FEI 1000132299, at 7053 ... Show Full Article WASHINGTON, Nov. 26 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Owen Biosciences Inc. from the Center for Drug Evaluation and Research: * * * Recipient: Dr. Donald R. Owen, Chief Executive Officer, Owen Biosciences, Inc., 7053 Revenue Drive, Baton Rouge, LA 70809-4918, United States Issuing Office: Center for Drug Evaluation and Research (CDER), United States Dear Dr. Owen: The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Owen Biosciences, Inc., FEI 1000132299, at 7053Revenue Drive, Baton Rouge, from March 25 to 27, 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 April 10, 2025 response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.
CGMP Violations
During our inspection, our investigator observed specific violations including, but not limited to, the following.
1. Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications designed to assure drug products conform to appropriate standards of identity, strength, quality, and purity. Your firm also failed to have, for each batch of drug product, an appropriate laboratory determination of satisfactory conformance to final specifications for drug products prior to release (21 CFR 211.160(b) and 211.165(a)).
Your firm manufactures various topical over-the-counter (OTC) drug products, including those containing the active ingredient benzoyl peroxide. There is a known degradation mechanism of benzoyl peroxide, under certain conditions, to form benzene, a known carcinogen. Your firm failed to establish scientifically sound and appropriate finished product specifications and failed to conduct benzene testing on your OTC topical drug products prior to release. For example, you manufactured and released at least (b)(4) lots of the (b)(4) 2.5% benzoyl peroxide acne lotion without testing for benzene. FDA laboratory analysis of one lot of (b)(4) 2.5% benzoyl peroxide acne lotion your firm manufactured and distributed yielded excessive benzene levels of more than 20 parts per million (ppm). You failed to ensure that your drug products do not contain unacceptable benzene impurity levels.
During the inspection, you informed our investigator that a retain sample of the FDA-tested lot as well as other lots manufactured of the (b)(4) 2.5% benzoyl peroxide acne lotion were sent to a contract testing laboratory (CTL) to conduct impurity and assay testing.
In your response, you mention that you will use a CTL to conduct benzene testing on the above-mentioned drug product. However, it is not clear if benzene testing will be performed on all lots prior to release. Your response also states that you are not aware of any FDA guideline on benzene testing, but FDA has alerted drug manufacturers of products at risk for presence of benzene that they should be testing those drug products for benzene. For more information see https://www.fda.gov/drugs/pharmaceutical-quality-resources/fda-alerts-drug-manufacturers-risk-benzene-contamination-certain-drugs.
Your response is inadequate because it does not detail any retrospective risk assessments (e.g., the actions that you will take) should any of the lots sent to your CTL for testing yield unacceptable benzene impurity levels. Further, your response lacks information that your CTL is qualified to test your drug products for benzene.
In response to this letter, provide:
* A list of chemical and microbial specifications, including test methods, used to analyze each lot of your drug product before a lot disposition decision.
* A detailed description of the method you establish to test for benzene in finished products prior to release.
* An action plan and timelines for conducting full chemical and microbiological testing of retain samples to determine the quality of all lots of drug product distributed to the United States that are within expiry as of the date of this letter.
* A summary of all results obtained from testing retain samples from each lot of benzoyl peroxide products that are currently on the U.S. market within expiry. If the testing reveals substandard-quality drug products, take rapid corrective actions, such as notifying customers and product recalls.
* 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.
2. Your firm failed to establish an adequate written testing program designed to assess the stability characteristics of drug products (21 CFR 211.166(a)).
Your stability program was not adequate to ensure that the OTC drug products you manufacture maintain their identity, strength, quality, purity, and safety throughout their shelf lives. For example, full shelf-life studies were not conducted for the entire stated expiry period. Additionally, the studies performed lacked adequate identity, microbiological, and impurities testing.
Your response is inadequate because it fails to include sufficient details on your stability program, including how you will ensure adequate ongoing stability testing with scientific justification. Additionally, it does not include a retrospective risk assessment or information on how you will ensure marketed drug products meet stability specifications throughout shelf life.
In your response to this letter, provide:
* A comprehensive, independent assessment and corrective action and preventive action (CAPA) plan to ensure the adequacy of your stability program. Your remediated program should include but not be limited to:
- Validated stability-indicating methods.
- Stability studies for each drug product in its marketed container-closure system before distribution is permitted.
- An ongoing program in which representative lots of each product are added each year to the program to determine if the shelf-life claim remains valid.
- Detailed definition of the specific attributes to be tested at each station (timepoint). Given that benzene is a known degradant of benzoyl peroxide and FDA analysis yielded excessive levels of benzene in your drug product, include benzene testing at each stability timepoint.
* All procedures that describe these and other elements of your remediated stability program.
3. Your firm's quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).
Your quality unit (QU) is inadequate. Your QU did not provide adequate oversight for the manufacture of your OTC drug products. For example, your QU failed to ensure:
* Review of production and control records to ensure completeness and accuracy (21 CFR 211.192).
* Adequate written procedures to document and investigate any unexplained discrepancy or failure of a batch or any of its components to meet any specifications (21 CFR 211.22(d); 21 CFR 211.192).
* Appropriate change control procedures were followed related to drug product manufacturing (21 CFR 211.22(d)).
* Performance of periodic (i.e., at least annual) product review (21 CFR 211.180(e)).
In your response, you state that you will address nonconforming products by quarantining the products and taking action to eliminate detected nonconformity. You also state that you will "follow the annual review of products," identify nonconforming products, and make any necessary adjustments with supporting documentation.
Your response is inadequate. You do not adequately detail how your quality function plans to improve its oversight of manufacturing quality. You also fail to assess the effects that your insufficient QU oversight had on product quality.
Your QU is responsible for fully exercising its authority and responsibilities. FDA is concerned that your QU may not be conducting appropriate oversight regarding CGMP operations.
Your firm's quality systems are inadequate. See FDA's guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations at https://www.fda.gov/media/71023/download for help with implementing quality systems and risk-management approaches to meet the requirements of CGMP regulations in 21 CFR 210 and 211.
Failed Commitment to Recall Contaminated Drug Lot
FDA sampled and tested one lot of Benzoyl Peroxide Acne Lotion that is used as part of the (b)(4) Acne System Kit. On March 4, 2025, FDA held a teleconference with the drug product distributor, (b)(4), to recommend removal of this product lot from the U.S. market because it contained excessive benzene impurity levels of more than 20 ppm. During that call and again on March 5, 2025, (b)(4) communicated that it would voluntarily recall the product containing the (b)(4) Benzoyl Peroxide Acne Lotion that FDA tested. However, neither Owen Biosciences, Inc. nor (b)(4) recalled the product before it expired.
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 assist your firm in meeting CGMP requirements.
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.
Responsibilities as a Contractor
Drugs must be manufactured in conformance with CGMP. FDA is aware that many drug manufacturers use independent contractors such as production facilities, testing laboratories, packagers, and labelers. FDA regards contractors as extensions of the manufacturer. You are responsible for the quality of drugs you produce as a contract facility regardless of agreements in place with product owners. You are required to ensure that drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act for safety, identity, strength, quality, and purity. See FDA's guidance document Contract Manufacturing Arrangements for Drugs: Quality Agreements at https://www.fda.gov/media/86193/download.
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.
Correct any violations promptly. Failure to adequately address this matter may lead to regulatory or legal action without further notice including, without limitation, seizure and injunction. Other Federal agencies may take your compliance history into account when considering the award of contracts.
Failure to address violations may be cause for FDA to withhold issuance of Export Certificates. Any violations of CGMP requirements may also be cause for FDA to withhold approval of new applications or supplements listing your firm as a drug manufacturer. We may re-inspect to verify that you have completed corrective actions to address any violations.
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 1000132299 and ATTN: Daniel W. Brisker.
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/owen-biosciences-inc-710275-10302025
FDA Issues Warning Letter to Hong Qiangxing Shenzhen Electronics Limited
WASHINGTON, Nov. 26 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Hong Qiangxing Shenzhen Electronics Limited from the Center for Devices and Radiological Health:* * *
Recipient: Zhu Shi Hong, Vice President and Management Representative, Hong Qiangxing Shenzhen Electronics Limited, 2F, Yongcheng Boulevard, Xicheng Industrial Area, Xixiang Road, Bao'an Qu Shenzhen Shi Guangdong Sheng, 518126, China, 1049936065@qq.com
Issuing Office: Center for Devices and Radiological Health, United States
Dear Zhu Shi Hong:
During ... Show Full Article WASHINGTON, Nov. 26 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Hong Qiangxing Shenzhen Electronics Limited from the Center for Devices and Radiological Health: * * * Recipient: Zhu Shi Hong, Vice President and Management Representative, Hong Qiangxing Shenzhen Electronics Limited, 2F, Yongcheng Boulevard, Xicheng Industrial Area, Xixiang Road, Bao'an Qu Shenzhen Shi Guangdong Sheng, 518126, China, 1049936065@qq.com Issuing Office: Center for Devices and Radiological Health, United States Dear Zhu Shi Hong: Duringan inspection of your firm located in Shenzhen, Guangdong, China, on August 4, 2025, through August 7, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures wrist blood pressure monitors, Belifu TENS001 (Model SM9126), and various transcutaneous electric nerve stimulators (TENS) and powered muscle stimulator (PMS) devices. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. Sec. 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.
Quality System Regulation Violations
This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. Sec. 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received responses from Zhu Shi Hong, Vice President and Management Representative, dated August 21, 2025, September 26, 2025, and October 8, 2025, concerning our investigator's observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm. We address these responses below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures to control the design of the devices to ensure that specified design requirements are met, as required by 21 CFR 820.30(a). Specifically:
a) Failure to adequately validate device software, as required by 21 CFR 820.30(g). Your firm failed to adequately verify and validate the operating software for the TENS and PMS Model SM9109A.
This is a repeat violation from the July 2016 inspection.
We reviewed your firm's August 21, 2025, September 26, 2025, and October 8, 2025, responses and conclude that they are not adequate. In these responses, your firm provided a corrective and preventive action (CAPA) report. The report identified the root causes as 1) lack of specific inspection and confirmation of the software during the burning process, and 2) lack of establishment of control procedures for the software burning process.
Your firm identified CAPAs to be taken as 1) establish the "Software burn-in Procedure," requiring the burn-in operators to confirm the burn-in version and conduct the initial burn-in inspection, carry out the burn-in process only after the initial inspection is passed, and conduct inspections and record the burn-in status every hour during the burn-in process; 2) record the software burn-in information, initial inspection results, and the burn-in process in a "Software burn-in Record;" and 3) conduct training for the engineering department on the new procedure. In the response dated October 8, 2025, your firm provided a copy of the newly established "Software Burning Procedure." However, the response does not address retrospective review to ensure that software on previously manufactured devices is validated.
b) Failure to adequately establish procedures for design change, as required by 21 CFR 820.30(i). Your change control procedures do not adequately ensure that the description of the change, the reason for the change, and the impact of the change is adequately evaluated and that the evaluation and results are documented. For example, three out of three change records reviewed involving changes to the TENS and PMS devices [Model SM9109A (RL-109A-6A1) and Model TENS7000 (RL-069)] and the Model SM 9019 (RL-0198-2C1) Remote Controller documented in ECN20240626001, ECN20231026001, and ECN20250425001 lacked adequate documentation of the change description, the reason for the change, and the evaluation of the impact of the change.
We reviewed your firm's August 21, 2025, September 26, 2025, and October 8, 2025, responses and conclude that they are not adequate. In these responses, your firm provided a CAPA report. The report identified the root causes as 1) a lack of planning for changes, resulting in insufficient information during the change process and absence of verification requirements, 2) a lack of planning for the changes due to the failure to implement an engineering change request (ECR) review or to effectively control the change process and verification, and 3) the absence of specific requirements for the execution and approval of ECR, so that verification was missing during the change process.
Your firm identified the following CAPAs in response: 1) update the COP-414-01 change control procedure and add the requirement that an ECR review must be conducted before the change, and 2) include in the ECR content the source of the change requirement, a comparison of devices before and after the change, an evaluation of the safety and effectiveness of the change impact, an assessment of foreseeable risks arising from the change, and a change verification plan, including a sampling plan, inspection basis record requirements, and sample requirements. Additionally, the report states that training will be conducted on the new "Change Control Procedure" and requirements of the ECR. The response dated October 8, 2025, includes evidence of the above described CAPAs, including an updated "Change Control Procedure." However, your response does not address retrospective review to ensure that all previous changes have been adequately documented and evaluated.
c) Failure to establish and maintain procedures for validating the device design, as required by 21 CFR 820.30(g). Your rationale for the sample size used in design validation for the low frequency Electronic Pulse Therapy Device Model SM9109A (RL-6A1) is not documented. Additionally, the device samples used in design validation were manufactured by the engineering department and were not produced under defined operating conditions as initial production units, lots, or batches or their equivalents. This is a repeat violation from the July 2016 inspection.
d) Failure to establish and maintain procedures for verifying the device design, as required by 21 CFR 820.30(f). Your rationale for the sample size used in design verification for the low frequency Electronic Pulse Therapy Device Model SM9109A (RL-6A1) is not documented. This is a repeat violation from the July 2016 inspection.
e) Failure to ensure that the design history file demonstrates that the design was developed following the requirements of 21 CFR 820, as required by 21 CFR 820.30(j). Your design verification and design validation for the low frequency Electronic Pulse Therapy Device Model SM9109A (RL-6A1) are inadequate in that the raw data in support of the design verification and validation are not documented, and that there are not documented manufacturing records for the samples used in verification and validation. This is a repeat violation from the July 2016 inspection.
We reviewed your firm's August 21, 2025, September 26, 2025, and October 8, 2025, responses and conclude that they are not adequate. In these responses, your firm provided a CAPA report. The report identifies the root causes as 1) a lack of planning for changes, resulting in insufficient information during the change process and absence of verification requirements, 2) a lack of planning for the changes due to the failure to implement an ECR review and the change process and verification were not effectively controlled, and 3) the absence of specific requirements for the execution and approval of an ECR so that verification was missing during the change process.
Your firm identified the following CAPAs in response: 1) update the COP-414-01 change control procedure and add the requirement that an ECR review must be conducted before the change, and 2) include in the ECR content the source of the change requirement, comparison of the device before and after the change, evaluation of the safety and effectiveness of the change impact, assessment of foreseeable risks arising from the change, and the change verification plan, including sampling plan, inspection basis record requirements, and sample requirements. Additionally, the report states that training will be conducted on the new "Change Control Procedure" and requirements of the ECR. The response dated October 8, 2025, includes evidence of the above described CAPAs, including an updated "Change Control Procedure." However, this response does not address systemically inadequate design verification and validation reports, including a lack of documentation of raw data in support of the design verification and validation and a lack of documented justification of sample size. Additionally, it does not ensure that device samples used in design verification and validation are manufactured under defined operating conditions as initial production units, lots, or batches, or their equivalents, or that documented manufacturing records confirm the samples are used in verification and validation under normal manufacturing conditions in cases when there is not a design change. Similarly, your response does not address retrospective review to ensure design verification and validation of any devices already made and/or in storage.
2. Failure to adequately establish procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a).
Specifically, COP-830-01, "Control of Nonconforming Product," does not ensure that the disposition of nonconforming product is documented or include a justification for use of nonconforming product. For example, a justification for use of nonconforming products is not documented in the Nonconforming Review and Disposal Form No. 20240103001. The dispositions of nonconforming products in Nonconforming Review and Disposal Forms No. 2025010803 and No. 2024082001 were also not documented.
Further, this is a repeat violation from the July 2016 inspection.
We reviewed your firm's August 21, 2025, September 26, 2025, and October 8, 2025, responses and conclude that they are not adequate. In these responses, your firm provided a CAPA report. Your firm identified root causes including that 1) the material on nonconformance handling forms identified in the inspection all underwent special acceptance and were approved but the special acceptance details were not recorded in the records; 2) there is no dedicated special acceptance review form established in the process of handling nonconforming products, so the special acceptance information is not reflected; and 3) there are no detailed procedures on the special acceptance process in COP-830-01, "Control of Nonconforming Product," resulting in incomplete special acceptance information.
Your firm identified CAPAs as: 1) establish the "special acceptance request" requiring that the special acceptance process must describe and approve the information and quantity, and specify any expected risks of the special acceptance materials; 2) reapply for special acceptance for the nonconforming product handling forms identified during the inspection to ensure the completeness of the special acceptance information; and 3) revise COP-830-01, "Control of Nonconforming Product," to add the "special acceptance request" requirement and stipulate that direct use, selective use, and production processing all fall under the "special acceptance" process. The "special acceptance request" form should be filled out by the department with special acceptance requirements, including the description of the nonconforming product, the expected risks generated by special acceptance, the special acceptance suggestions, and the quantity of special acceptance. After being approved by relevant departments and the management representative, special acceptance can be carried out.
In the response dated October 8, 2025, your firm provided evidence of the above described CAPA, including an updated COP-830-01 procedure with a section on a "Special Procurement Application," specifying conditions in which nonconforming materials can be used for specific purposes after appropriate approval. Your firm also provided copies of a "Special Acceptance Request" form, filled out per the "Special Procurement Application" process, for the specific cases referenced in this observation. However, the responses do not address retrospective review to ensure that any other previous nonconformance handling forms not reviewed during the inspection are also appropriately reviewed and documented according to the updated procedure.
3. Failure to adequately establish procedures for corrective and preventive action as required by 21 CFR 820.100(a).
Specifically, a) the corrective and preventive action procedures do not ensure that sources of quality data are adequately analyzed to identify existing and potential causes of nonconforming product or other quality problems; b) CAPA 2025022501 was not adequately investigated to identify corrective actions and the effectiveness of the actions taken was not verified; and c) the effectiveness of the actions taken in CAPA 2025060401 were not verified.
We reviewed your firm's August 21, 2025, September 26, 2025, and October 8, 2025 responses and conclude that they are not adequate. In these responses, your firm provided a CAPA report. Your firm identified the root causes for inadequacies in these two CAPA forms as 1) a delay in receiving complaint information from American distributors and confirmation of the problem which required no adjustment to the complaint from the distributor, and 2) a lack of stipulation in COP-821-01, "Customer Complaint Feedback Control Procedure," for the handling of defective products after they are returned, such that the quality department did not update the CAPA, and 3) a lack of regulations in COP-630-01, "Facility and Equipment Management Procedure," for the handling of facilities and equipment after adjustment, such that the engineering department did not conduct any verification after implementing a change resulting from a complaint.
Your firm's proposed CAPA includes 1) re-examining the root cause analysis of the first CAPA form to confirm the fundamental reason for the problem that led to the returned product, 2) re-validating the corrective action and providing the investigation and verification results to the customer, and 3) revising COP-821-01, "Customer Feedback Control Procedure," to add the requirement that "After the customer returns the defective products due to complaints, re-inspection shall be conducted to confirm whether the defects are consistent with the descriptions provided by the distributor or the user." Additionally, the actions include 1) carrying out small-scale trial production of the adjusted line speed of the packaging line to verify the effectiveness of the previous corrective action, and 2) updating COP-630-01, "Facility and Equipment Management Procedure," and adding the requirement that "Facility and equipment should be adjusted according to production requirements. After the adjustment, it needs to undergo small-scale trial production verification to confirm the adjustment [is] effect[ive] before use." The response dated October 8, 2025, provided evidence of the above described CAPA, including copies of the revised CAPA forms and an updated COP-630-01 procedure. However, the responses do not address how your firm will validate the effectiveness of future CAPAs or include retrospective review to ensure effectiveness of other previous CAPA reports.
4. Failure to adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).
Specifically, the complaint handling procedures do not ensure that complaints are processed in a uniform and timely manner or that they are adequately investigated and evaluated for submission of a medical device report (MDR). For example, 4 out of 4 complaints reviewed were not adequately investigated and lacked documented MDR evaluation. One of the complaint records reviewed, Customer Complaint Form No. 23081101, included two separate reported malfunctions of two different TENS and PMS devices received on different dates from the same customer. Your firm failed to create separate reports to adequately process, investigate, and evaluate each complaint.
Your firm's responses, dated August 21, 2025, September 26, 2025, and October 8, 2025, appear to be adequate. In these responses, your firm provided a CAPA report. Your firm identified root causes, including that the review requirements for the submission of an FDA MDR were not reflected on the customer complaint handling form, so the marketing department did not assess the MDR requirements. In one complaint (number 23081101), the customer mentioned both the ZX-518BM and the 587B device models, but the inventory checks were recorded on a single form. As there were no specific requirements in the complaint feedback control procedure for situations where a single complaint involved multiple device models or products, the investigation did not distinguish between them. Your firm identified CAPAs, including 1) revising the customer complaint handling form QR-821-05/00 to add the FDA MDR assessment requirements, 2) re-evaluating the customer complaints handling from 2025, 2024, and 2023 to determine whether an FDA MDR is necessary, 3) revising the customer feedback control procedure COP-821-01 to add information about MDR procedures, and 4) revising the customer feedback control procedure COP-821-01 to specify that if a complaint involves multiple products or different models, a separate investigation needs to be conducted for each product or model. In the response dated October 8, 2025, your firm provided evidence of the CAPA investigation, including an updated version of the COP-821-01 procedure.
5. Failure to adequately establish procedures for identifying product during all stages of receipt, production, distribution, and installation, as required by 21 CFR 820.60.
Specifically, during the walk through inspection, the investigator observed an unidentified box of what appeared to be in-process, partly assembled TENS and PMS units on a work bench and a case of unidentified in-process, semi-assembled TENS and PMS units stored on a pallet on the floor near a soldering workstation in the production room. In various areas, such as in the receiving/shipping and production rooms, there were unidentified, opened and half-opened boxes and a variety of materials and production and test equipment that your firm stated were obsolete and no longer in use.
Your firm's responses, dated August 21, 2025, September 26, 2025, and October 8, 2025, appear to be adequate. In these responses, your firm provided a CAPA report. Your firm identified root causes including: 1) a failure of the production department to properly organize materials in time due to the large volume of production tasks and the abundance of materials, 2) a lack of production environment control measures that resulted in the production materials not being assigned to specific storage areas, and 3) a lack of production environment control procedures, leading to a lack of production environment inspections and the disorderly placement of materials.
Your firm identified CAPAs including 1) establish production environment control procedures to set requirements for the placement of materials in the production area and the cleanliness of the environment, and 2) establish a checklist for the production environment and conduct daily inspections of the production environment. In the response dated October 8, 2025, your firm provided evidence of the CAPA implementation, including a copy of the newly established "Production Environment Management Regulations" procedure and a production environment inspection record form demonstrating inspection of the production environment beginning in mid-August 2025.
Other federal agencies may take your compliance with the Federal Food, Drug, and Cosmetic (FD&C) Act and its implementation regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed.
Please notify this office in writing, within fifteen business days from the date you receive this letter, of the specific steps your firm has taken to address the noted violations, including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm's planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Please provide a translation of documentation not in English to facilitate our review. We will notify you regarding the adequacy of your firm's response(s) and the need to re-inspect your firm's facility to verify that the appropriate corrections and/or corrective actions have been made. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.
Your firm's response should be sent via email to Tushar Bansal, Ph.D., at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, CMS case # 718112 when replying. If you have any questions about the contents of this letter, please contact: Tushar Bansal, Ph.D., at Tushar.Bansal@fda.hhs.gov.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm's facility. It is your firm's responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations and take prompt actions to address any violations and bring the products into compliance.
Sincerely,
/S/ David McMullen, M.D., Director, OHT5: Office of Neurological and Physical Medicine Devices, Office of Product Evaluation and Quality, Center for Devices and Radiological Health
CC:
Mark Gordon
1800 Byberry Road Suite 905
Huntingdon Valley, PA 19006
920-601-9045
(b)(6)@outlook.com
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Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hong-qiangxing-shenzhen-electronics-limited-718112-10282025
Comptroller of the Currency: Agencies Issue Proposal to Enhance Community Banks' Ability to Serve Their Communities While Maintaining Strong Capital Requirements
WASHINGTON, Nov. 26 -- The U.S. Department of the Treasury Office of the Comptroller of the Currency issued the following joint news release on Nov. 25, 2025:* * *
Agencies Issue Proposal to Enhance Community Banks' Ability to Serve Their Communities While Maintaining Strong Capital Requirements
The federal bank regulatory agencies today invited public comment on a proposal that would implement changes to the community bank leverage ratio framework in accordance with statutory authority. By incorporating these changes, the revisions would reduce regulatory burden and provide community banks ... Show Full Article WASHINGTON, Nov. 26 -- The U.S. Department of the Treasury Office of the Comptroller of the Currency issued the following joint news release on Nov. 25, 2025: * * * Agencies Issue Proposal to Enhance Community Banks' Ability to Serve Their Communities While Maintaining Strong Capital Requirements The federal bank regulatory agencies today invited public comment on a proposal that would implement changes to the community bank leverage ratio framework in accordance with statutory authority. By incorporating these changes, the revisions would reduce regulatory burden and provide community bankswith greater flexibility and optionality in their capital management approach. The proposal reflects a deeper understanding of the unique business models, risk profiles, and operational realities of community banks. These tailored modifications represent a necessary step in continuing to focus attention on the unique needs of community banks in today's financial landscape.
The community bank leverage ratio, adopted in 2019, simplifies regulatory capital requirements for community banks by allowing them to adopt a relatively simple leverage ratio to measure capital adequacy. A bank that opts into the framework is not required to calculate and report risk-based capital ratios.
The proposal would lower the community bank leverage ratio requirement to eight percent from the current nine percent. The proposal would also extend the grace period, from two quarters to four quarters, for a community bank that opts into the framework and falls out of compliance to come back into compliance.
The proposal would continue to require a level of capital that is consistent with ensuring the safety and soundness of community banks and comparable to-or higher than-the amount required under the risk-based capital framework. It would also maintain a leverage ratio that is double the minimum leverage ratio applicable to community banks that do not opt into the framework.
These changes demonstrate the agencies' ongoing commitment to focusing attention on community banks and their vital role in local economies, while ensuring appropriate safeguards remain in place. The proposed modifications provide community banks with enhanced options to manage their regulatory obligations while maintaining their ability to serve their communities.
Comments on the proposal are due 60 days after publication in the Federal Register.
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Original text here: https://occ.gov/news-issuances/news-releases/2025/nr-ia-2025-111.html
Alma Avenue Gang Member and Brother, Both Prior Felons, Facing New Drug and Gun Charges
BUFFALO, New York, Nov. 26 -- The office of the U.S. Attorney for the Western District of New York posted the following news release on Nov. 25, 2025:* * *
Alma Avenue gang member and brother, both prior felons, facing new drug and gun charges
U.S. Attorney Michael DiGiacomo announced today that Kevin Miller, 35, of Buffalo, NY, was arrested and charged by criminal complaint with possession with intent to distribute, and distribution of, five grams or more of methamphetamine, which carries a mandatory minimum penalty of five years in prison, a maximum of 40 years, and a $5,000,000 fine. In ... Show Full Article BUFFALO, New York, Nov. 26 -- The office of the U.S. Attorney for the Western District of New York posted the following news release on Nov. 25, 2025: * * * Alma Avenue gang member and brother, both prior felons, facing new drug and gun charges U.S. Attorney Michael DiGiacomo announced today that Kevin Miller, 35, of Buffalo, NY, was arrested and charged by criminal complaint with possession with intent to distribute, and distribution of, five grams or more of methamphetamine, which carries a mandatory minimum penalty of five years in prison, a maximum of 40 years, and a $5,000,000 fine. Inaddition, Kevin's brother, Kaylen Miller, 28, of Lackawanna, NY, was arrested and charged in a separate criminal complaint with being a felon in possession of a firearm and possession with intent to distribute crack cocaine, which carries a maximum penalty of 20 years in prison and a $1,000,000 fine.
According to the complaints, Kevin Miller was charged after he made two controlled sales of methamphetamine to an undercover officer. Since 2019, the FBI Safe Streets Task Force, along with the Lackawanna and Buffalo Police Departments, have been investigating the drug trafficking activities of Kevin Miller, an Alma Avenue Gang member with a prior federal narcotics conviction.
Kevin's brother, Kaylen Miller, was also charged as the result of the execution of a search warrant by law enforcement that resulted in the recovery of a loaded handgun, suspected cocaine, drug paraphernalia and $2,005.00 in cash. Further investigation determined that the recovered handgun had been reported stolen in Cleveland, Ohio. Kaylen Miller was prohibited from possessing the gun due to a prior felony conviction.
"Kevin and Kaylen Miller have a documented history of criminal behavior, which they have both been prosecuted and punished for in the past," stated U.S. Attorney DiGiacomo. "These brothers clearly did not learn a lesson the first time around and are now being held accountable once again for their actions. Let these newest charges serve as a reminder that my Office, together with our law enforcement partners, will continue our efforts to keep defendants like the Miller brothers from filling our community with drugs, guns, and violence."
"Kevin and Kaylen Miller are previously convicted felons, who, once again, find themselves, in federal custody. These arrests and seizures demonstrate our relentless determination to remove gun and drug-fueled violence from our city," said Philip Tejera, Special Agent-in-Charge of the FBI's Buffalo Field Office. "The FBI's Safe Streets Task Force is proud to work side by side with the Lackawanna and Buffalo Police Departments, and the U.S. Attorney's Office to bring these individuals to justice."
According to Assistant U.S. Attorney Donna Duncan, Kaylen and Kevin Miller appeared before U.S. Magistrate Judge Michael J. Roemer today. Judge Roemer ordered Kevin Miller to be detained and released Kaylen Miller on conditions.
The complaints are the culmination of an investigation by the Federal Bureau of Investigation, under the direction of Special Agent-in-Charge Philip Tejera, the Buffalo Police Department, under the direction of Commissioner Alphonso Wright, and the Lackawanna Police Department, under the direction of Chief Mark Packard.
The fact that a defendant has been charged with a crime is merely an accusation and the defendant is presumed innocent until and unless proven guilty.
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Original text here: https://www.justice.gov/usao-wdny/pr/alma-avenue-gang-member-and-brother-both-prior-felons-facing-new-drug-and-gun-charges