Inspections, Compliance, Enforcement, and Criminal Investigations
Seafood Marketing US, Inc. 08-Aug-06
Department of Health and Human Services
Public Health Service
555 Winderley PI., Ste. 200
RETURN RECEIPT REQUESTED
August 8, 2006
Hammeris V. Garzon, Secretary
(U.S. Registered Agent)
Seafood Marketing US, Inc.
11430 SW 88th Street
Miami, FL 33176-1057
Dear Mr. Garzon:
We inspected your seafood importer establishment, located at the above address on July 5 and 7, 2006. 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 frozen cooked farm raised shrimp 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 home page at www.fda.gov.
Your significant violations were as follows:
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 affirmative steps for canned pasteurized crabmeat manufactured by [redacted] that is not adequate. Specifically, your firm failed to maintain a written guarantee from the foreign processor.
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.
In addition, review of the foreign processor's HACCP plan for cooked shrimp revealed the HACCP plan lists a critical limit, of internal cooking temperature equal to or higher than 72°C, at the cooking critical control point that is not adequate to control the food safety hazard of pathogen survival. The critical limits listed did not address or indicate the length of the cooking cycle and cooking temperature. We encourage you to contact your foreign supplier of this deviation and to make the appropriate correction.
Additionally, during the inspection your firm supplied our investigator with a copy of a document which appears to be a continuing certificate dated December 22, 2005 thru December 21, 2008. This certificate is not adequate in that it does not address the provisions listed under 21 CFR123. If a continuing certificate were to be obtained, the certificate would need to be updated on an annual basis.
Furthermore, your firm has not developed product specifications for the cooked shrimp imported from your foreign supplier in accordance with 21 CFR 123.12 (a)(2)(i).
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.
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, 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.
Emma R. Singleton
Director, Florida District
Emma R. Singleton!