Inspections, Compliance, Enforcement, and Criminal Investigations
Tropical Marine Products Inc. 02-May-06
Department of Health and Human Services
Public Health Service
555 Winderley PL, Ste. 200
RETURN RECEIPT REQUEST
May 2, 2006
Carlos Jose Franco, President
Tropical Marine Products Inc.
7101 NW 77th Terrace
Medley, FL 33166
Dear Mr. Franco:
We inspected your seafood importer establishment, located at 7101 NW 77th Terrace, Medley, FL 33166 on February 2-3, 2006 and an amended FDA-483 was issued to you on February 14, 2006 concerning this inspection. We found that you have a serious violation 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 fresh mahi-mahi is adulterated under Section 402(a)(4)of the Act (21 U.S.C. § 342(a)(4)), in that it has been prepared, packed, or held under insanitary conditions whereby it 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 violation is as follows:
1. You must implement an affirmative step which ensures that the fish and fishery product(s) you import are processed in accordance with the seafood HACCP regulation, to comply with 21 CFR 123.12(a)(2)(ii). However, your firm performed an affirmative step for fresh mahi-mahi from [redacted] that is not adequate. Specifically, your firm failed to obtain a written guarantee from the firm. Also the HACCP plan from [redacted] is not signed or dated and possibly was not implemented at that firm.
We may take further action if you do not promptly correct this violation. 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."
In addition, your firm did not have written verification procedures including product specifications and the affirmative step(s) your firm has elected to follow to ensure that the fish and fishery products your firm imports into the United States were processed in accordance with the HACCP requirements. You promised full correction and that documentation would be forwarded to our office within thirty days from the conclusion of the inspection. To date, we have not received any written response from your firm.
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 all violations. You should include in your response these documentation, such as verification procedures 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.
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.
Please send your reply to the Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida 32751, Attention: Shari H. Shambaugh. If you have questions regarding any issues in this letter, please contact Ms. Shambaugh at 407-475-4730.
Emma R. Singleton
Director, Florida District