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Surface Transportation Board Issues Decision Involving 4 Companies
WASHINGTON, May 6 -- The U.S. Department of Transportation Surface Transportation Board issued the following decision (Docket No. FD 36873) entitled "Union Pacific Corp. and Union Pacific Railroad Co. - Control - Norfolk Southern Corp. and Norfolk Southern Railway Co.":* * *
On April 30, 2026, Union Pacific Corporation (UPC), Union Pacific Railroad Company (UP), Norfolk Southern Corporation (NSC), and Norfolk Southern Railway Company (NS) (collectively, Applicants) filed a revised application (the Revised Application) seeking Board approval for the acquisition of control by UPC of NSC, and through ... Show Full Article WASHINGTON, May 6 -- The U.S. Department of Transportation Surface Transportation Board issued the following decision (Docket No. FD 36873) entitled "Union Pacific Corp. and Union Pacific Railroad Co. - Control - Norfolk Southern Corp. and Norfolk Southern Railway Co.": * * * On April 30, 2026, Union Pacific Corporation (UPC), Union Pacific Railroad Company (UP), Norfolk Southern Corporation (NSC), and Norfolk Southern Railway Company (NS) (collectively, Applicants) filed a revised application (the Revised Application) seeking Board approval for the acquisition of control by UPC of NSC, and throughNSC of NS and NS's rail carrier subsidiaries, and the resulting common control by UPC of UP and NS and the consolidation of the rail operations of UP and NS.
That same day, the Board served a decision setting a deadline of May 8, 2026, at noon EDT for comments on whether the Revised Application contains the information required in 49 C.F.R. part 1180, and permitting Applicants to file a reply by May 12, 2026, at 5 p.m. EDT. Union Pac. Corp.-- Control--Norfolk S. Corp., FD 36873 (STB served Apr. 30, 2026).
On May 4, 2026, Grand Trunk Corporation (CN) filed a letter noting that access to certain workpaper databases related to the verified statements of Applicants' witnesses were unavailable until Sunday, May 3, 2026 due to encryption issues, and asked that the Board therefore consider the Revised Application not to have been filed until the next business day, Monday, May 4. Applicants filed a reply to CN's letter on May 5, 2026, acknowledging the encryption issue and stating that it promptly addressed CN's concerns and provided access to the workpapers on Sunday. Applicants argue, among other things, that modifying filing dates based on changes to supporting documents in complex proceedings involving voluminous workpaper submissions is irreconcilable with normal practice before the Board..
The Board's regulations require applicants, for a major application, to provide "[s]upporting data for the analyses . . . including shipper surveys and econometric or other statistical analyses" and that "applicants shall make these data available in a repository for inspection by other parties or otherwise supply these data on request." 49 C.F.R. Sec. 1180.7(b)(7); see also Union Pac. Corp.--Control--Norfolk S. Corp., FD 36873 et al., slip op. at 6-8 (STB served Aug. 28, 2025) (providing instructions for workpapers). Applicants promptly rectified the workpaper access issue upon notification from CN in this instance. See also Union Pac. Corp.--Control--Norfolk S. Corp., FD 36873 et al., slip op. at 2 (STB served Jan. 2, 2026) (requiring Applicants to provide notice regarding any updated or replacement workpapers). Accordingly, the application filing date will not be reset.
Nevertheless, the deadline for comments on whether the Revised Application contains the information required in 49 C.F.R. part 1180 will be adjusted to provide some additional time, consistent with the timeframe for the Board's determination. Such comments will be due by May 8, 2026, at 11:59 p.m. EDT. All other schedule dates will remain the same.
It is ordered:
1. Comments, limited to whether the Revised Application contains the information required in 49 C.F.R. part 1180, may be filed by May 8, 2026, at 11:59 p.m. EDT, and Applicants may file a reply by May 12, 2026, at 5 p.m. EDT.
2. This decision is effective on its service date.
By the Board, Anika S. Cooper, Chief Counsel, Office of Chief Counsel.
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Footnote:
1/ This decision also embraces Union Pacific Corp.--Control--Peoria & Pekin Union Railway, Docket No. FD 36873 (Sub-No. 1).
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Original text here: https://dcms-external.s3.amazonaws.com/DCMS_External_PROD/178/53042.pdf
Secretary of State Rubio Targets Iranian "Hostage" Tactics with New U.N. Resolution to Secure Strait of Hormuz
WASHINGTON, May 6 -- The U.S. State Department issued the following statement on May 5, 2026, by Secretary Marco Rubio regarding a proposed United Nations Security Council resolution aimed at countering Iranian aggression and securing freedom of navigation in the Strait of Hormuz:* * *
The Islamic Republic of Iran continues to hold the world's economy hostage with its efforts to close the Strait of Hormuz, threats to attack ships in the Strait, laying of sea mines that pose a danger to shipping, and attempts to charge tolls for the world's most important waterway.
At President Trump's direction, ... Show Full Article WASHINGTON, May 6 -- The U.S. State Department issued the following statement on May 5, 2026, by Secretary Marco Rubio regarding a proposed United Nations Security Council resolution aimed at countering Iranian aggression and securing freedom of navigation in the Strait of Hormuz: * * * The Islamic Republic of Iran continues to hold the world's economy hostage with its efforts to close the Strait of Hormuz, threats to attack ships in the Strait, laying of sea mines that pose a danger to shipping, and attempts to charge tolls for the world's most important waterway. At President Trump's direction,the United States, alongside Bahrain and our Gulf partners, Saudi Arabia, the United Arab Emirates, Kuwait, and Qatar, drafted a UN Security Council Resolution to defend freedom of navigation in the Strait of Hormuz.
The draft resolution requires Iran to cease attacks, mining, and tolling.
It demands that Iran disclose the number and location of the sea mines it has laid and cooperate with efforts to remove them, while also supporting the establishment of a humanitarian corridor.
The United States looks forward to this resolution being voted on in the coming days and to receiving support from Security Council members and a broad base of co-sponsors.
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Original text here: https://www.state.gov/releases/office-of-the-spokesperson/2026/05/the-united-states-proposes-a-un-security-council-resolution-to-defend-freedom-of-navigation-and-secure-the-strait-of-hormuz/
FDA Human Foods Program Issues Warning Letter to South Bay Cold Storage & Handling
WASHINGTON, May 6 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to South Bay Cold Storage and Handling Inc. from its Human Foods Program:* * *
Recipient: Jacob P. Bochove, Owner/CEO, South Bay Cold Storage & Handling, Inc., 1351 Elwood Street, Los Angeles, CA 90021-2412, United States, JBochove@gmail.com
Issuing Office: Human Foods Program, United States
WARNING LETTER
Re: CMS #717080
Dear Mr. Bochove:
The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, located ... Show Full Article WASHINGTON, May 6 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to South Bay Cold Storage and Handling Inc. from its Human Foods Program: * * * Recipient: Jacob P. Bochove, Owner/CEO, South Bay Cold Storage & Handling, Inc., 1351 Elwood Street, Los Angeles, CA 90021-2412, United States, JBochove@gmail.com Issuing Office: Human Foods Program, United States WARNING LETTER Re: CMS #717080 Dear Mr. Bochove: The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, locatedat 1351 Elwood Street, Los Angeles, CA 90021, from July 1, 2025, through July 8, 2025. During our inspection, the FDA investigator found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123.
Based on FDA's inspectional findings, we have determined your scombroid species, vacuum-packed Dungeness crab and blue crabmeat and vacuum-packed smoked salmon products are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. Sec. 342(a)(4)) in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. Furthermore, in accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with 21 CFR 123.6 whenever a HACCP plan is necessary or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Act, 21 U.S.C. Sec. 342(a)(4). You may find the Act, the seafood HACCP regulation, and the June 2022 4th Edition of the Fish and Fisheries Products Hazards & Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov.
At the conclusion of the inspection, the FDA investigator issued your facility a Form FDA 483 (FDA-483), Inspectional Observations, listing the deviations found at your firm. You provided a response to the FDA-483 on July 23, 2025, including your revised undated HACCP Plan for "SCOMBROID," revised undated HACCP Plan for "Dungeness Crab, Blue Crabmeat / Vacuum Packed products," and revised undated HACCP Plan for "Salmon Smoked/ Vacuum Packed Products." Your written response did not include any supporting HACCP documentation. After reviewing your response, we are issuing this letter to advise you of FDA's concerns and to provide detailed information describing the findings at your facility. We also address your response below.
Seafood HACCP Violations (21 CFR Part 123)
Your significant violations of the seafood HACCP regulation are as follows:
1. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a), and (b). Specifically, your firm does not have a HACCP plan to control the food safety hazard of undeclared allergens associated with your repackaging of different fish species. During our inspection, your firm was repackaging halibut without a HACCP plan.
2. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123(c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However:
a. Your revised HACCP plan for "Salmon Smoked/ Vacuum Packed Products" submitted with your July 23, 2025, response lists a critical limit in the plan for receiving refrigerated product that does not ensure the temperature of the product was held at or below an ambient or internal temperature of (b)(4) F ((b)(4) C) throughout transit. Your plan lists "(b)(4)" as the critical limit at the "(b)(4)" critical control point. Your response does not list the Clostridium botulinum hazard associated with receiving refrigerated vacuum-packed smoked salmon. Your firm should specify the Clostridium botulinum hazard at this receiving CCP.
b. Your revised HACCP plan for "SCOMBROID" submitted with your July 23, 2025, response lists a critical limit in the plan for receiving refrigerated product that does not ensure the temperature of the product was held at or below an ambient or internal temperature of (b)(4) F ((b)(4) C) throughout transit. Your plan lists "(b)(4)" as the critical limit at the "(b)(4)" critical control point. FDA recommends that refrigerated scombroid species be accompanied by transportation records showing the fish were held under 40 F throughout transit or the fish are received completely surrounded by ice.
c. Your revised HACCP plan for "Dungeness Crab, Blue Crabmeat / Vacuum Packed products" submitted with your July 23, 2025, response lists a critical limit in the plan for receiving refrigerated product that does not ensure the temperature of the product was held at or below an ambient or internal temperature of (b)(4) F ((b)(4) C) throughout transit. Your plan lists "(b)(4)" as the critical limit at the "(b)(4)" critical control point. It is important that processors ensure incoming seafood products were held at or below 40 F continuously during transit.
3. You must have a HACCP plan that, at a minimum, list monitoring procedures and their frequencies for each critical control point to comply with 21 CFR 123.6(c)(4). The monitoring procedure listed for the following HACCP plans are not adequate to control the hazards that are reasonably likely to occur:
a. Your revised HACCP plan for "Salmon Smoked/ Vacuum Packed Products" submitted with your July 23, 2025, response lists "(b)(4)" at the "(b)(4)" critical control point to monitor and control the Clostridium botulinum hazard associated with storing the vacuum-packed salmon received, stored and distributed by the firm. However, the plan does not list checking the data logger visually at least (b)(4) per day.
b. Your revised HACCP plan for "SCOMBROID" submitted with your July 23, 2025, response lists "(b)(4)" at the "(b)(4)" critical control point to monitor and control the Scombrotoxin (Histamine) hazard associated with the storage of yellowfin tuna, and anchovies observed in your coolers on July 1 to July 8, 2025. However, the plan does not list checking the data logger visually at least (b)(4) per day.
c. Your revised HACCP plan for "Dungeness Crab, Blue Crabmeat/Vacuum Packed products" submitted with your July 23, 2025, response lists "(b)(4)" at the "(b)(4)" critical control point to monitor and control the Clostridium botulinum hazard associated with storing the reduced oxygen packaging /vacuum packed Dungeness crabmeat and blue crabmeat distributed by your firm. However, the plan does not list checking the data logger visually at least (b)(4) per day.
4. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure, at a minimum, compliance with the current good manufacturing practice requirements in 21 CFR 117, Subpart B (CGMPs) and maintain records of your observations as required by 21 CFR 123.11(b). However, you did not ensure all food contact surfaces, including utensils, were cleaned as necessary to protect against the food contamination as required by 21 CFR 117.35(d). This is related to the condition and cleanliness of food contact surfaces, as required by 21 CFR 123.11(b)(2).
Specifically, on July 1, 2025, your sanitation employee stated he does not use detergent to clean the shovels used to pick up ice. On July 1, 2025, inside of cooler #(b)(4), ice was observed in direct contact with mesh bags containing mussels, inside plastic bags directly in contact with live ready-to-eat oysters and added directly to fish on July 2, 2025.
The violations cited in this letter are not intended to be an all-inclusive list 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 facility 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, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.
Please notify FDA in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to address these violations, including an explanation of each step being taken to prevent the recurrence of violations, as well as providing copies of related documents. If you cannot complete all corrections within fifteen (15) 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.
Please send your reply to the Food and Drug Administration, Attention: Bruce E. Taylor, Compliance Officer, Human Foods Program - Office of Compliance and Enforcement, Office of Enforcement - Division of Conventional Foods Enforcement (HFS-607), 5001 Campus Drive, College Park, MD 20740. If you have any questions regarding any issues in this letter, please contact Bruce E. Taylor via email at: Bruce.Taylor@fda.hhs.gov. Please include CMS reference #717080 on any submissions and within the subject line of any email correspondence to the agency.
Sincerely,
/S/ Thomas Kuntz, Acting Deputy 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/south-bay-cold-storage-handling-inc-717080-01222026
FDA Human Foods Program Issues Warning Letter to Pita Pan Bakery
WASHINGTON, May 6 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to RSV Pita Inc. dba Pita Pan Bakery from its Human Foods Program:* * *
Recipient: Mr. Salomon Vidal, Owner, RSV Pita, Inc. DBA Pita Pan Bakery, 8602 NW 44th St, Lauderhill, FL 33351-6006, United States, solyvidal@icloud.com
Issuing Office: Human Foods Program, United States
WARNING LETTER
Re: CMS # 719561
Dear Mr. Vidal:
The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) food manufacturing facility, located at 8602 NW ... Show Full Article WASHINGTON, May 6 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to RSV Pita Inc. dba Pita Pan Bakery from its Human Foods Program: * * * Recipient: Mr. Salomon Vidal, Owner, RSV Pita, Inc. DBA Pita Pan Bakery, 8602 NW 44th St, Lauderhill, FL 33351-6006, United States, solyvidal@icloud.com Issuing Office: Human Foods Program, United States WARNING LETTER Re: CMS # 719561 Dear Mr. Vidal: The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) food manufacturing facility, located at 8602 NW44th Street, Lauderhill, FL 33351-6006, from May 28, 2025 to June 11, 2025. During our inspection of your facility, an FDA investigator found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117).
Based on FDA's inspectional findings, we have determined that food including pita, bagels, and challah, manufactured in your facility is adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. Sec. 342(a)(4)], in that they were prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act and further information about the CGMP & PC rule through links on FDA's homepage at www.fda.gov.
Further, your Jerusalem Bagel, Sesame Pita Bread, and Challah Sesame Bread products are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. Sec. 343(w)], in that the finished product label fails to declare the major food allergens, as required by section 403(w)(1) of the Act.
At the conclusion of the inspection, the FDA investigator issued your facility a Form FDA 483 (FDA-483), Inspectional Observations, listing the deviations found at your firm. To date, we have not received a response to the FDA 483. After reviewing the inspectional findings, we are issuing this letter to advise you of FDA's continuing concerns and to provide detailed information describing the findings at your facility.
Current Good Manufacturing Practice Requirements (21 CFR Part 117, Subpart B)
Your significant violations are as follows:
1. You did not clean and sanitize your equipment in a manner and as frequently as necessary to protect against allergen cross contact and contamination of food as required by 21 CFR 117.35(d). Specifically,
a. On May 29, 2025, your firm manufactured challah bread dough containing eggs on the mixer machine bowl, dough divider, and proofer. The same equipment was used to manufacture Jerusalem bagel dough that does not contain eggs without cleaning the shared food contact surfaces between the products. This practice does not protect your products from allergen cross contact.
b. On May 28 and May 29, 2025, the mixer machine was observed to be cleaned only with water and that the dough divider, pan sheeter machine, and the oven conveyor belt were not taken apart for cleaning. Cleaning consists of removing excess dough, and food residues with a brush and compressed air. On May 29, 2025, the oven conveyor belt, which was in direct contact with RTE pita, was encrusted with what appear to be old food residues between the metal links. On May 28, 2025, while manufacturing pita the left side of pan liner sheet of the pan sheeter machine had old, dry black food residues. The pan liner sheet was also torn and visibly damaged. The brushes used to clean the equipment were observed in disrepair and do not appear to be easily cleanable. These practices to not protect against contamination.
c. Your proofer cloth pan liners that are in direct contact with dough balls are not cleaned on a daily basis. On May 29, 2025, you manufactured challah bread dough containing eggs followed by Jerusalem bagel dough which contacted the cloth pan liners. This practice does not protect against allergen cross contact and contamination.
d. On May 29, 2025, one of your employees was observed washing and rinsing utensils at the three compartments sink and placed them to air dry without completing the (b)(4) step first. These utensils were previously used to apply the egg wash on the in-process challah bread.
2. You did not conduct all food manufacturing, processing, packing, and holding under such conditions and controls as are necessary to minimize the potential for contamination of food, as required by 21 CFR 117.80(c)(2). Specifically:
a. On May 28, 2025 and May 29, 2025, dust and flour accumulation were observed encrusted on plastic curtains that divide the processing area from the retail area and on plastic curtains dividing the packaging area from the retail area. Employees were observed transporting uncovered RTE challah bread manufactured on May 29, 2025, which came into direct contact with the curtains located in the processing area and the packaging area.
b. On May 29, 2025 in the processing room, uncovered RTE pita bread was observed moving along the open oven conveyor belt passing adjacent to unshielded fluorescent light fixtures and an air conditioning vent. Both fixtures had visible dust and flour residue accumulation.
c. On May 28, 2025, uncovered in-process Jerusalem bagels with sesame seeds were stored underneath an unshielded light inside the walk-in-cooler.
d. In the packaging area, a rolling cart holding uncovered RTE challah bread that was manufactured on May 29, 2025, was observed directly being stored underneath damaged ceiling tile with watermarks and gaps in the tile.
e. During the (b)(4) of RTE pita bread that was manufactured on May 29, 2025, the back exit door was being held open with (b)(4) opened bags of flour placed directly on the floor. This practice does not protect against contamination of your raw material flour and entrance of pests.
3. You did not take reasonable measures and precautions to ensure that all persons working in direct contact with food, food-contact surfaces, and food packaging materials conform to hygienic practices while on duty to the extent necessary to protect against contamination of food, as required by 21 CFR Sec. 117.10(b). Specifically, investigators observed multiple instances of poor hygienic practices including:
a. On May 29, 2025, during the packaging process of RTE challah bread, an employee was observed using their cell phone while handling and packaging RTE sesame challah bread first and then immediately proceeded to handle and package RTE challah bread without sesame seeds. The employee did not wash hands or change gloves in between handling these products with different allergen profiles or after handling their cellphone.
b. On May 28, 2025 and May 29, 2025, during the processing of RTE challah bread, Jerusalem bagels and pita bread, your employees did not wash their hands before donning and putting on gloves to start (b)(4) the RTE products. No hand washing was observed after touching their face and clothes, using their cell phones, and after performing cleaning activities before resuming hand contact with ready to eat foods.
c. On May 28, 2025 and May 29, 2025, male employees with facial hair were observed working with in-process and RTE products without wearing beard covers.
d. On May 28, 2025 and May 29, 2025, personal beverage bottles were observed stored on top and underneath preparation tables in processing areas. Additionally, one personal beverage bottle was stored inside the reach in freezer used to store frozen RTE pita bread and your employees were observed actively drinking water while working in the processing areas. Furthermore, a piece of bread for personal consumption was observed on top of a preparation table in the processing room.
e. On May 29, 2025, during the packaging of RTE pita bread, your employees were observed wearing torn gloves with holes on them while handling and packaging the RTE product.
f. On May 29, 2025, during the processing of challah bread dough, one of your employees was observed entering the processing room without a hair restraint.
4. Your plant equipment and utensils used in manufacturing and processing are not designed and of such material and workmanship as to be adequately cleanable, and adequately maintained to protect against contamination, as required by 21 CFR 117.40(a). Specifically, on May 28, 2025 and May 29, 2025 during the manufacturing of RTE challah breads, Jerusalem bagels, and pita bread investigators observed the following in the processing room:
a. Plywood trays were used to place in-process Challah breads and Jerusalem bagels at the end of the (b)(4) step. The interior surface of these trays was observed with food debris accumulation. In addition, wooden tables used to package ready to eat products were found with peeled paint, visible cracks, and grooves on it.
b. During (b)(4) that were observed attached with clear plastic tape. These (b)(4) with clear plastic tape cannot be easily cleaned and sanitized to protect against allergen cross-contact and contamination.
c. A spatula used to remove excess dough from food contact surfaces was observed with clear plastic tape on the handle and cannot be easily cleaned and sanitized.
d. The outer canvas flap at the exit point of the oven used to bake pita bread is frayed and burnt. This outer canvas flap was observed in direct contact with the RTE pita bread that was manufactured on May 29, 2025, while exiting the oven.
Misbranding Violations
Your Jerusalem Bagel, Sesame Pita Bread, and Challah Sesame Bread products are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. Sec. 343(w)], in that the finished product label fails to declare the major food allergens, as required by section 403(w)(1) of the Act. Specifically, your Jerusalem Bagel product is manufactured using flour that contains wheat. Your Sesame Pita Bread and Challah Sesame Bread products are manufactured with sesame.
Section 201(qq) of the Act [21 U.S.C. Sec. 321(qq)], defines "major food allergens" as milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and sesame as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refined oils. A food is misbranded under section 403(w) of the Act if it is not a raw agricultural commodity and it is, or it contains, an ingredient that bears or contains, a major food allergen, unless either:
* The word "Contains" followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients, section 403(w)(1)(A) of the Act [21 U.S.C. Sec. 343(w)(1)(A)]: or
* The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived (e.g., "Whey (Milk)"), except the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen), section 403(w)(1)(B) of the Act [21 U.S.C. Sec. 343(w)(1)(B)].
The violations cited in this letter are not intended to be an all-inclusive list of the violations that may exist at your facility or in connection with your products. You are responsible for investigating and determining the cause of the violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure your facility complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to do so may result in legal action without further notice, including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.
In addition to the violations described above, we offer the following comment:
Your facility appears to meet the definition of a qualified facility/1 under the Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food rule (CGMP & PCHF rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117), subject to the modified requirements in 21 CFR 117.201. A qualified facility is required to submit an attestation to FDA that the facility is a qualified facility (21 CFR 117.201(a)(1)). In addition, a qualified facility is required by 21 CFR 117.201(a)(2) to submit one of the two following attestations to FDA:
An attestation that you have identified the potential hazards associated with the food being produced, are implementing preventive controls to address the hazards, and are monitoring the performance of the preventive controls to ensure that such controls are effective; or
An attestation that the facility is in compliance with State, local, county, tribal, or other applicable non-Federal food safety law, including relevant laws and regulations of foreign countries, including an attestation based on licenses, inspection reports, certificates, permits, credentials, certification by an appropriate agency (such as a State Department of Agriculture), or other evidence of oversight.
To date you have not submitted such an attestation.
Please notify FDA in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to address these violations, including an explanation of each step being taken to prevent the recurrence of violations, as well as providing copies of related documents. If you cannot complete all corrections within fifteen (15) days, state the reason for the delay and the time frame 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.
Please send your written response electronically to: HFP-OCE-ConventionalFoods@fda.hhs.gov, copying Kerry Kurdilla, Compliance Officer, at Kerry.Kurdilla@fda.hhs.gov. Please include reference CMS # 719561 on any submissions and within the subject line of any email correspondence to the agency. If you have questions regarding this letter, please contact Kerry Kurdilla, Compliance Officer, at Kerry.Kurdilla@fda.hhs.gov.
Sincerely,
/S/ Maria S. Knirk, JD MBA, Acting Director, Office of Enforcement, Office of Compliance and Enforcement, Human Foods Program
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Footnote:
1/ See definition of "qualified facility" in 21 CFR 117.3.
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Original text here: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/rsv-pita-inc-dba-pita-pan-bakery-719561-12182025
FDA Center for Drug Evaluation & Research Issues Warning Letter to Respilon Production S.R.O.
WASHINGTON, May 6 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Respilon Production S.R.O. from its Center for Drug Evaluation and Research:* * *
Recipient: Mr. Roman Zima, Chief Executive Officer, Respilon Production S.R.O., Prikop 843/4 Brno, 602 00 Jihomoravsky, Czechia
Issuing Office: Center for Drug Evaluation and Research (CDER), United States
Warning Letter 320-26-69
Dear Mr. Zima:
Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) ... Show Full Article WASHINGTON, May 6 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Respilon Production S.R.O. from its Center for Drug Evaluation and Research: * * * Recipient: Mr. Roman Zima, Chief Executive Officer, Respilon Production S.R.O., Prikop 843/4 Brno, 602 00 Jihomoravsky, Czechia Issuing Office: Center for Drug Evaluation and Research (CDER), United States Warning Letter 320-26-69 Dear Mr. Zima: Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC)drug products. FDA has reviewed the records you submitted in response to our May 2, 2025, request and subsequent correspondence, for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for your facility, Respilon Production S.R.O, FEI 3018892481, at Prikop 843/4, Brno, Jihomoravsky, Czech Republic.
This Warning Letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21, Code of Federal Regulations, parts 210 and 211 (21 CFR parts 210 and 211).
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding of drugs as described in your response to our 704(a)(4) request 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)).
Following our review of records and other information you provided pursuant to section 704(a)(4) of the FD&C Act, significant violations were observed including but not limited to, the following:
1. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier's test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).
Your response to our request for records under section 704(a)(4) indicated that you do not test the identity of each incoming component used in the manufacture of your drug products, such as (b)(4), before manufacturing.
In addition, you failed to test each shipment of (b)(4) for (b)(4) contamination before use. Identity testing for (b)(4) and certain other high-risk drug components includes a limit test in the United States Pharmacopeia (USP) to ensure that the component meets the relevant safety limits for levels of (b)(4). Because you did not perform adequate identity testing on each shipment of each lot using the USP identification test that detects these hazardous impurities, you failed to ensure the acceptability of these components for use in the manufacturing of your drug product. See FDA's guidance document (b)(4) for help in meeting the CGMP requirements when manufacturing drugs containing ingredients at high risk for (b)(4) contamination.
2. Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products (21 CFR 211.166(a)).
Your response to our request for records under section 704(a)(4) indicated that you have not performed stability studies for the OTC drug products you manufacture, despite your drug product's displaying an expiration date on the label.
Without the appropriate stability studies, you do not have scientific evidence to support whether your drug product's active ingredient maintains its strength, purity, and quality throughout the shelf life of the product.
3. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).
Your response to our request for records under section 704(a)(4) indicated that you failed to adequately validate your drug manufacturing processes to demonstrate that they are reproducible and controlled. Process validation evaluates the soundness of design and the state of control of a process throughout its life cycle. Each significant stage of a manufacturing process must be designed appropriately and must ensure the quality of raw material inputs, in-process materials, and finished drugs. Process qualification studies include intensive monitoring and testing throughout each significant process stage to characterize intra-batch variation and to evaluate batches to determine whether an initial state of control has been established.
4. Your firm failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods (21 CFR 211.165(e)).
Your response to our request for records under section 704(a)(4) indicated that you failed to adequately validate the test method used to analyze raw materials and finished drug products. Method validation or verification has not been completed for the active ingredient assay testing for (b)(4). Your analytical method does not demonstrate specificity, accuracy, precision, and robustness. Additionally, it appears that your firm is not performing microbiological testing for each batch of your drug products before release. In your response, you state that your drug product has low (b)(4) at less than (b)(4) and that microbial proliferation is not possible. However, you have not validated your overall manufacturing process or conducted stability studies to determine if microbial contamination proliferates throughout the shelf life of the product. You have not provided a comprehensive microbial risk assessment of your manufacturing steps, such as in-process hold times, storage conditions, and the microbial load of your (b)(4) ingredients. The statement in your response that you intend to conduct reduced microbial testing is insufficient, based on the limited information you provided and the lack of documentation to support your approach.
5. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (211.194(a)).
Your response to our request for records under section 704(a)(4) indicated that your finished drug product's Certificate of Analysis did not provide an individual test result for (b)(4) content. The "Batch Production" record that you provided as your Certificate of Analysis states "PASSED" in the "Conformity" section but does not provide an assay result.
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. The qualified consultant should also perform a comprehensive six-system audit1 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.
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. 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 inspect to verify that you have completed corrective actions to any violations.
Failure to address any violations may also result in the FDA refusing admission of articles manufactured at Respilon Production S.R.O., Prikop 843/4, Brno, Jihomoravsky, Czech Republic 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 3018892481 and ATTN: Erika V. Butler.
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/respilon-production-sro-719705-04202026
DEGRE Wargame an "Essential Tool" for Modern Deterrence
OFFUTT AIR FORCE BASE, Nebraska, May 6 -- The U.S. Strategic Command issued the following news:* * *
DEGRE wargame an "Essential Tool" for modern deterrence
NEWPORT, R.I. - U.S. Strategic Command, in collaboration with the U.S. Naval War College, conducted the annual Deterrence and Escalation Game and Review to examine and refine strategic deterrence concepts. The exercise brings together military leadership, strategists, and allied partners to explore decision-making in a simulated global crisis.
The primary objective of DEGRE is to study the dynamics of deterrence and escalation management. ... Show Full Article OFFUTT AIR FORCE BASE, Nebraska, May 6 -- The U.S. Strategic Command issued the following news: * * * DEGRE wargame an "Essential Tool" for modern deterrence NEWPORT, R.I. - U.S. Strategic Command, in collaboration with the U.S. Naval War College, conducted the annual Deterrence and Escalation Game and Review to examine and refine strategic deterrence concepts. The exercise brings together military leadership, strategists, and allied partners to explore decision-making in a simulated global crisis. The primary objective of DEGRE is to study the dynamics of deterrence and escalation management.The wargame is designed to test a "Whole-of-Government" approach, involving participants from various U.S. combatant commands alongside allied nations. This intensive, multi-day event challenges senior leaders to navigate complex geopolitical scenarios, ensuring the nation's strategic forces are prepared for the challenges of the 21st century.
Leadership from both organizing bodies have highlighted the wargame's role in preparing for the dynamic strategic environment.
"In today's multi-polar nuclear landscape defined by rapid technological change, wargames like DEGRE are indispensable," said Adm. Rich Correll, commander of U.S. Strategic Command. "DEGRE serves as a critical proving ground, allowing us to rigorously test our assumptions, integrate joint force capabilities across domains, and transform deterrence concepts from strategy to operational reality. Through this wargame, we demonstrate our force is not only safe, secure, effective, and credible, but also adaptable--guaranteeing the broadest array of military options, with the Joint Force, for the President and the Secretary of War."
The structure of the wargame allows participants to gain insights into an opponent's potential decision-making processes. By simulating the perspectives of adversaries and partners, U.S. leaders can better anticipate reactions and refine their own strategies, ultimately strengthening the stability of the global security environment.
United states Strategic Command working closely with the U.S. Naval War College, designs, develops, and executes the annual event. The college's deep expertise in strategic studies and wargaming provides the intellectual foundation for the exercise.
"The U.S. Naval War College is uniquely positioned to support U.S. Strategic Command as it considers the full range of deterrent options available to decision-makers as conditions around the world evolve," said Rear Adm. Darryl Walker, president, U.S. Naval War College. "Our researchers and military experts can provide the latest insights into adversary motivations and behaviors, as well as capabilities and limitations. We can help USSTRATCOM critically think through multiple courses of action and understand how to achieve our most favorable outcomes and options for our civilian leadership. It's crucial the U.S. military always stays two or three steps ahead of the next decision point in all situations and across all domains, and the U.S. Naval War College truly helps us do that."
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Original text here: https://www.stratcom.mil/Media/News/News-Article-View/Article/4477887/degre-wargame-an-essential-tool-for-modern-deterrence/
Consumer Financial Protection Bureau Report: 'GAO-IG Act Reporting'
WASHINGTON, May 6 (TNSres) -- The Consumer Financial Protection Bureau issued the following report on April 30, 2026, entitled "GAO-IG Act Reporting."Here are excerpts:
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1. Introduction
On January 3, 2019, the Good Accounting Obligation in Government Act (GAO-IG Act or Act) was enacted as Public Law number 115-414. This report is published by the Consumer Financial Protection Bureau (Bureau or CFPB) in compliance with that law.
The GAO-IG Act requires agencies to annually submit a report to Congress on the status of certain open public audit recommendations. To comply with the requirements ... Show Full Article WASHINGTON, May 6 (TNSres) -- The Consumer Financial Protection Bureau issued the following report on April 30, 2026, entitled "GAO-IG Act Reporting." Here are excerpts: * * * 1. Introduction On January 3, 2019, the Good Accounting Obligation in Government Act (GAO-IG Act or Act) was enacted as Public Law number 115-414. This report is published by the Consumer Financial Protection Bureau (Bureau or CFPB) in compliance with that law. The GAO-IG Act requires agencies to annually submit a report to Congress on the status of certain open public audit recommendations. To comply with the requirementsof the Act, this report contains the following sections: (1) open Government Accountability Office (GAO) recommendations, and (2) open Office of the Inspector General (OIG) of the Board of Governors of the Federal Reserve System (FRB) recommendations.
The GAO-IG Act also requires an agency to disclose discrepancies between its report and reports issued by the GAO and OIG. The CFPB is not aware of any discrepancy between this report and public reports issued by the GAO or OIG.
1.1 Background
The CFPB was established on July 21, 2010, under Title X of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act) as a bureau within the Federal Reserve System. The CFPB is an Executive agency as defined in Section 105 of Title 5, United States Code. As an Executive agency and under the Dodd-Frank Act, the CFPB is subject to external audits and reviews, some of which are legislatively mandated, others of which are conducted at the discretion of the oversight body.
Audits and reviews conducted by the GAO and OIG can be categorized as follows:
* GAO Annual Financial Statement Audit: This annual audit is to determine whether the CFPB's financial statements were fairly presented and whether the CFPB's management maintained effective internal control over financial reporting. The annual GAO financial statement audit is a requirement of the Dodd-Frank Act, 12 U.S.C. Sec. 5496a(b).
* GAO Subject Matter Engagements: These engagements are performed at the request of congressional members, committees, or subcommittees, may be mandated by public laws or committee reports, or are undertaken at GAO's own initiative.
3 CONSUMER FINANCIAL PROTECTION BUREAU
OIG: The OIG conducts audits, investigations, and other reviews of the CFPB's program functions. Section 1081 of the Dodd-Frank Act amended the Inspector General Act of 1978 (IG Act) to create one Inspector General for both the FRB and the CFPB and provide the OIG with all the authorities and responsibilities provided by the IG Act with respect to the CFPB.
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View full report at: https://files.consumerfinance.gov/f/documents/cfpb_gao-ig-act-report-cy2025_2026-04.pdf