FDA WARNING_LETTER - T & L Trading Inc - February 06, 2015
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On April 16, 2015, the FDA issued a Warning Letter to T & L Trading, Inc. following an inspection from February 4-6, 2015. The inspection revealed serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110).
The FDA determined that the firm's live King crab and live halibut products were adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions.
Specific violations included: * **Lack of Product Specifications (21 CFR 123(a)(2)(i)):** The firm did not have product specifications for imported live King crab and live halibut to ensure they were not injurious to health or processed under insanitary conditions. * **Failure to Implement Affirmative Step (21 CFR 123.12(a)(2)(ii)):** The firm lacked an affirmative step for imported live halibut. * **Insufficient Monitoring of Sanitation Conditions (21 CFR 123.11(b) and 21 CFR Part 110):** * **Safety of Water:** Mold-like substance was observed on water pipes and holding
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