Inspections, Compliance, Enforcement, and Criminal Investigations
Miami Terminal Cold Storage, LLC 23-Jul-07
Department of Health and Human Services
Public Health Service
555 Winderley Pl., Ste. 200
RETURN RECEIPT REQUESTED
July 23, 2007
Miami Terminal Cold Storage, LLC
Lee E. Sigler, President
1301 NW 89th Court, Suite 214
Miami, Florida 33172-3008
Dear Mr. Sigler:
We inspected your seafood importer an d warehouse establishment, located at the above address on May- 14, 15, and 18, 2007. 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).
As an importer of fish or fishery products, you must operate in accordance with the requirements of 21 CFR 123.12. 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 products have been processed under conditions 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 Act, 21 U.S.C. §342(a)(4).
Accordingly, your raw, fresh, refrigerated mahi mahi and canned; pasteurized, refrigerated crabmeat 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 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 raw, fresh, refrigerated mahi mahi manufactured by [redacted]
2. Since you chose to include corrective actions in your HACCP plans, your described corrective actions must be appropriate; to comply with 21 CFR 123.7(b): However, your corrective action plans for canned, pasteurized, refrigerated crabmeat and raw, fresh, refrigerated scombroid species of fish at the receiving critical control point to control the significant hazards of pathogen growth, toxin formation (specifically Clostridium botulinum), and histamine formation are not appropriate in that the corrective action plans for critical limit deviations fail to include the discontinuation of use of a supplier or carrier until evidence is obtained that transportation practices have changed.
In addition, you must have written verification procedures and product specifications that are designed to ensure that the fish and fishery products you import are not injurious to health, to comply with 21 CFR 123.12(a)(2)(i). However, your firm does not have written verification procedures and product specifications for raw, fresh, refrigerated mahi mahi imported from Ecuador. Also, no one associated with your firm has completed the required HACCP training or is HACCP qualified through job experience to comply with 21 CFR 123.10. We note that this observation was also included on the form FDA 483 issued to your firm on November 14, 2005. You may find a schedule of seafood HACCP training opportunities in your area through links in FDA's home page at www.fda.gov.
We acknowledge the changes made to your firm's corrective action plans for critical limit deviations at the receiving critical control point for canned, pasteurized, refrigerated crabmeat and raw, fresh, refrigerated scombroid species of fish during the inspection. Your inclusion of the discontinuation of use of a supplier or carrier until evidence is obtained that transportation practices have changed in the corrective action plan for each product appears adequate.
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 products, 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, records that document the performance and results of your firm's affirmative steps, HACCP and verification records associated with your activities as a domestic processor, revised HACCP plans bearing the signature of the authorizing official and date on which the revision(s) are effective, 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 establishment operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part l10). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations for your fish or fishery products, including those that you import into the United States.
Please send your reply to the Food and Drug Administration, Attention: Matthew B. Thomaston, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have questions regarding any issues in this letter, please contact Mr. Thomaston at (407) 475-4728.
Emma R. Singleton
Director, Florida District