Inspections, Compliance, Enforcement, and Criminal Investigations
Twin Tails Seafood Corp. 18-Apr-06
Department of Health and Human Services
Public Health Service
555 Winderley PL, Ste. 200
RETURN RECEIPT REQUESTED
April 18, 2006
Guillermo J. Sarria, President
Twin Tails Seafood Corp.
8236 NW 30 Terrace
Miami, FL 33122
Dear Mr. Sarria:
We inspected your seafood importer establishment, located at 8325 NW 30 Terrace on March 13 & 15, 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 products have 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 of 21 CFR Part 123, your crabmeat is 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.
1. You must implement an affirmative step which ensure 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 canned pasteurized crabmeat imported from [redacted]
2. You must implement the monitoring procedures and record keeping system that you have listed in your HACCP plan, to comply with 21 CFR 123 .6(b). However, your firm did not follow the monitoring procedure and frequency of checking cooler temperature and 24-hour digital read out thermometers visually 4 times a day at the receiving critical control point to control C. Botulinum and pathogen growth for canned pasteurized crabmeat. In addition, monitoring records were not maintained and your firm does not have recording thermometers nor back up cooler alarms in any of the 3 coolers at your facility.
In addition to the above cited deviations, a piece of moldy plastic was observed in the ice machine, your firm's HACCP plans have not been updated to reflect your firm's new address, your HACCP plans have not been signed and dated, you did not review some of your calibration records within a reasonable amount of time after the records were generated, and your records do not include the name, location of the processor or importer and date and time of the activity performed.
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.
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 records such as, monitoring record examples that document the performance and results of your firm's affirmative steps, and / 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 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: Virginia L. Meeks, 555 Winderley Place Suite 200 Maitland, FL 32571. If you have questions regarding any issues in this letter, please contact Ms. Meeks at (407) 475-4731.
Emma R. Singleton
Director, Florida District