The United States Food and Drug Administration (FDA) inspected your seafood processing facility located at 100 Plantation Pointe, Fairhope, AL 36532 on October 19, 20 and 25, 2021. Our inspection found you have serious violations of the Seafood Hazard Regulations, Part 123 (21 CFR Part 123(g), failure of a seafood processor to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with requirements of Part 123, renders the fish or fishery products 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). Accordingly, your seafood products are adulterated because they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the 4th Edition of the Fish and Fishery Products Hazards and Controls Guidance (the Hazards Guide) through links on FDA’s home page at www.fda.gov.External Link Disclaimer
FDA’s inspection resulted in the issuance of a FORM FDA 483, Inspectional Observations, listing deviations found during our inspection. We received your response, via email on October 25, 2021. After reviewing the inspectional findings and your response to the observations listed in the FORM FDA483, we are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility.
Your significant violations were 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). However, you do not have a HACCP Plan for fresh sushi-grade salmon to control the parasite and environmental hazards.
In your response sent on October 25, 2021 you state a HACCP plan will be devised once you complete a seafood HACCP certification course. However, you did not provide documentation of enrollment into a seafood HACCP course. Additionally, no timeline was provided for completion of your HACCP plan.
2. You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). Specifically, you do not have sanitation control records that document the monitoring of the following key areas of sanitation:
a. Condition and cleanliness of food contact surfaces, such as tables and utensils.
b. Prevention of cross-contamination from insanitary objects.
c. Maintenance of hand washing, hand sanitizing, and toilet facilities.
d. Protection of food, food packaging material, and food contact surfaces from adulteration.
e. Proper labeling, storage and use of toxic compounds.
f. Control of employee health conditions.
In your response sent on October 25, 2021 you state that you monitor sanitation controls utilizing daily and monthly logs. However, no supporting documentation was provided.
3. To comply with 21 CFR 123.10, you must have an individual who has successfully completed training in the application of HACCP principles to fish and fishery product processing that is at least equivalent to that received under a standardized curriculum recognized as adequate by the U.S. Food and Drug Administration or who may otherwise be qualified through job experience to perform the following functions: (1) the development of the HACCP plan, as required by 21 CFR 123.6(b); (2) the reassessment and modification of the HACCP plan in accordance with the corrective action procedures specified in 21 CFR 123.7(c)(5); (3) the reassessment and modification of the HACCP plan in accordance with the verification activities specified in 21 CFR 123.8(a)(1);(4) the reassessment and modification of the hazard analysis in accordance with the verification activities specified in 21 CFR 123.8(c); and (5) perform the record review required by 21 CFR 123.8(a)(3).
In your response sent on October 25, 2021 you state that you will be attending an online seafood HACCP certification course; however, no documentation of enrollment into the course was provided.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations. Your response should include documentation reflecting the corrections you made, such as a copy of your HACCP plan. You should also provide five (5) consecutive days of completed monitoring records to demonstrate implementation of your HACCP plan.