Inspections, Compliance, Enforcement, and Criminal Investigations
Dunedin Fish Company 2/12/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
RETURN RECEIPT REQUESTED
February 12, 2009
Bruce W. Lee, President
Dunedin Fish Company
5018 North Hubert Avenue
Tampa, FL 33614-6437
Dear Mr. Lee:
We inspected your seafood establishment, located at the above address on November 5, 7 and 12,2008. 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). The specific requirements for imported fish and fishery products are set out in 21 CFR 123.12. As an importer of fish or fishery products, you must operate in accordance with the requirements of Part 123. In accordance with 21 CFR 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part 123.
If assurances do not exist that the imported fish or fishery product has been processed under conditions that are equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4),and will be denied entry. Because our inspection identified serious violations for 21 CFR Part 123, your Scombrotoxin forming fish (i.e.mahi-mahi) are adulterated under Section 402(a)(4) of 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. You may find the Act, the seafood HACCP regulation, and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's homepage at www.fda.gov.
Your significant violations were as follows:
> You must implement an affirmative step which ensures that the fish and fishery products you import are processed in accordance with the seafood HACCP regulation, to comply with 21 CFR 123.12(a)(2)(ii). However your firm did not perform an affirmative step for mahi-mahi manufactured by (b)(4)
This letter may not list all the violations at your facility. You are responsible for ensuring that your seafood importer establishment operates in compliance with the Act and the seafood HACCP regulation (21 CFR Part 123). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations for the fish or fishery products that you import into the United States.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act (21 U.S.C. § 381(a), including placing them on "detention without physical examination," seize your product(s), and/or enjoin your firm from further violating the Act.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation, such as HACCP and importer verification records and records that document the performance and results of your firm's affirmative steps, 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.
Please send your reply to the Food and Drug Administration, Attention: Brant M. Schroeder, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have any questions regarding any issue in this letter, please contact Mr. Schroeder at (407) 475-4763. We look forward to working with you to achieve a successful HACCP program.
Emma R. Singleton
Director, Florida District