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WARNING LETTER

City Market, Inc. MARCS-CMS 727003 —

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, to comply with 21 CFR 123.6(c)(3). Your firm’s HACCP plan for pasteurized crab meat lists critical limits at your receiving and storage critical control points (CCPs) that are not adequate to control C. botulinum growth and toxin formation.

  • At your receiving CCP, your critical limit of “(b)(4)” is not adequate. Because you indicated that you received pasteurized crab meat refrigerated or with ice, your HACCP plan should cover each manner that the product is received. When pasteurized crab meat is received refrigerated without ice the critical limit should list that the product is held at an ambient temperature 40°F or below with continuous temperature monitoring throughout transit for each shipment. When product is received on ice, the critical limit should list product is to be completely surrounded by ice at the time of delivery with monitoring the amount of ice in a designated number of containers from each shipment selected to be representative. Additionally, as a verification procedure you should periodically measure the internal temperature of the product to ensure that the ice is sufficient to maintain 40°F or below.
  • At your storage CCP, your critical limit of “(b)(4)” is not adequate. Because product was observed in your cooler without ice your critical limit should list product is held in a cooler with an ambient air temperature of 40°F or below with continuous temperature monitoring with a visual check of the recorded data at least daily.

3. Corrective actions are to prevent the distribution of adulterated food into commerce and correct the cause of the deviation to comply with 21 CFR 123.7(b).

  • At your receiving CCP, your corrective action of “(b)(4)” is not adequate because it does not include correction to the cause of the deviation. Your corrective actions should list reject shipments and discontinue use of supplier until evidence of improved transport practices has been obtained.
  • At your storage CCP, your corrective action of “(b)(4)” is not adequate because it does not ensure adulterated product does not enter commerce and the cause of the deviation is corrected. Your corrective actions should list chill and hold the affected product until a food safety evaluation of the cumulative time and temperature exposures is conducted, and discard any product determined to be unsafe. Your corrective actions should also list correction to the cause of deviation such as repair the cooler or provide employee training to prevent leaving the cooler door open, as observed during the inspection.

4. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice (cGMP) requirements under 21 CFR 117, subpart B that are appropriate to your plant and food products (21 CFR 123.11(b)). During the inspection, our investigator observed that the last sanitation monitoring record completed by firm management was dated September 15, 2025, through September 21, 2025. Additionally, during the inspection the investigator observed several insanitary conditions including uncovered fish in the cooler; debris at the freezer entry; condensate and water dripping from the freezer cooling unit; sanitizer solution of an unknown concentration used to soak processing equipment and no test strips to verify chemical concentration. This is a repeat observation from the previous inspection conducted on January 9, 2023. You should review the Sanitation Control Procedures for Processing Fish and Fishery Products guidance for sanitation procedures and monitoring.

5. Your firm does not have records documenting food hygiene and food safety training for employees as defined in 21 CFR 117.4(d). You could not provide employee training records for food hygiene and food safety because your firm does not have a training program. For seafood HACCP and sanitation training to comply with 21 CFR 123.10 and for assistance with creating an employee training program see the Seafood HACCP Training and Education - Florida Sea Grant website.

Your response to this Warning Letter should provide your corrective actions and supporting documentation that includes a revised HACCP plan with CCP monitoring records and sanitation monitoring records for at least five consecutive production days to demonstrate implementation.

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 receipt of this letter as to the specific steps you have taken to address any 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 corrective actions within fifteen (15) working 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 reply to HFP-OCE-ConventionalFoods@fda.hhs.gov, copying Bruce Taylor, Compliance Officer, at Bruce.Taylor@fda.hhs.gov or by hard copy to 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 reference CMS #727003 on any submissions and within the subject line of any email correspondence to the agency.

Sincerely,
/S/

Maria S. Knirk, JD MBA
Director
Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program

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