FDA Warning Letter to City Market, Inc. (May 15, 2026) — Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions

FDA Warning Letter — Violations FDA cited at City Market, Inc.

WARNING LETTER City Market, Inc. MARCS-CMS 727003 — May 15, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA ELECTRONIC DELIVERY Product: Food & Beverages Recipient: Recipient Name Frank H. Owens Jr. Recipient Title Owner City Market, Inc. 1508 Gloucester Street Brunswick , GA 31520-7143 United States frankowensjr76@gmail.com Issuing Office: Human Foods Program United States May 15, 2026 WARNING LETTER Re: CMS #727003 Dear Mr. Owens: The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility located at 1508 Gloucester Street, Brunswick, GA 31520, from January 7, 2026, through January 9, 2026. 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 that your ready-to-eat pasteurized canned crab meat is adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 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. § 342(a)(4). You may find the Act, the seafood HACCP regulation, and the June 2022 Edition of the Fish and Fisheries Products Hazards and 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. To date, we have not received a response to the FDA-483 issued to you on January 9, 2026. We are issuing this letter to advise you of FDA’s concerns and to provide detailed information describing the findings at your facility. Your significant violations of the seafood HACCP regulation are as follows: 1. You did not implement the monitoring procedures listed in your HACCP plan for the receiving and storage of pasteurized canned crab meat to control the hazard of Clostridium botulinum (C. botulinum) growth and toxin formation to comply with 21 CFR 123.6(b). During receiving, your firm did not implement the listed monitoring procedure of using a temperature monitoring device for the finished product temperature during shipping. During storage, your firm did not implement the listed monitoring procedure of visually observing the quantity of ice. Your firm did not have monitoring records for the receiving and storage of pasteurized canned crab meat. Additionally, on January 7, 2026, pasteurized canned crab meat that was received by your firm in December of 2025, was stored in your cooler without ice while other cans were stored with ice, but not with a sufficient amount of ice to completely surround each can. Furthermore, the thermometer located inside the cooler measured the ambient air temperature to be approximately (b)(4) °F at the beginning of the inspection and after three hours approximately (b)(4) °F. Pasteurized canned crab meat is thermally processed to control non-proteolytic C. botulinum and should be held at 40°F to control proteolytic C. botulinum . When temperatures are between 50°F and 70°F, the maximum cumulative exposure time limit to control proteolytic C. botulinum is 11 hours. After 11 hours, the product is considered to be unsafe due to potential formation of botulinum toxin, the deadliest known toxin. 2. You must have a HACCP plan that at a minimum lists the critical limits that must be met