|Company:||Fisherman's Catch Seafood Market|
|Subject:||Seafood HACCP/CGMP for Foods/Adulterated|
|Issuer:||Atlanta District Office|
|Issued:||Jan. 19, 2011||Closed:||
Department of Health and Human Services
Public Health Service
Food and Drug Administration
Atlanta District Office
January 19, 2011
VIA UNITED PARCEL SERVICE
Greg McGimsey, Owner
Fisherman's Catch Seafood Market
919 E. Union Street
Morganton, NC 28655-2840
Dear Mr. McGimsey:
We inspected your seafood processing establishment, located at 919 E. Union Street, Morganton, NC 28655-2840 between September 15 and September 21, 2010. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123), and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). 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 this section 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 Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4).
Accordingly, your tuna loins and mahi mahi seafood products are adulterated, in that 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 Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov .
Your significant violations were as follows:
1) You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan, that at a minimum, lists the critical control points, to comply with 21 CFR 123.6(a) and (c)(2). A critical control point is defined in 21 CFR 123.3 (b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels."
However your firm's HACCP plan for crabmeat, submitted with your undated response to the Inspectional Observations, Form FDA 483, does not list the critical control point of storage for controlling the food safety hazard of pathogen growth and potential toxin formation.
2) You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm's HACCP plan for Mahi Mahi, Tuna, Amberjack, and Wahoo does not list the monitoring procedure/frequency at the receiving critical control point to control histamine formation. Your plan does not instruct employees to check for the adequacy of ice on the fish. For fish that are held under ice, FDA recommends checking for the adequacy of ice at receiving. Employees should assure that ice completely surrounds the fish.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you have done, since your undated correspondence, to correct these violations. You should include in your response documentation such as HACCP and verification records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to the Food and Drug Administration, Attention: Serene N. Ackall, Compliance Officer, 60 Eighth St., NE, Atlanta, GA 30309. If you have questions regarding any issues in this letter, please contact Ms. Ackall at 404-253-1296.
John R. Gridley, Director