FDA WARNING_LETTER - Newport Lobster Company, Inc. - December 15, 2010

The FDA inspected Newport Lobster Company, Inc. from November 23 to December 15, 2010, and found serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110). Consequently, their ready-to-eat cooked lobster meat, tuna, and pasteurized crabmeat products are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Failure to implement record-keeping systems (21 CFR 123.6(b) and (c)(7)):** The firm did not record monitoring observations for routine lobster meat cooking, twice-daily ice presence at cooler storage for RTE cooked lobster meat, RTE pasteurized crabmeat, and raw tuna, or receiving data for RTE pasteurized crabmeat and raw tuna. 2. **Inappropriate corrective actions (21 CFR 123.7(b)):** Corrective action plans for RTE pasteurized crabmeat and raw tuna at the "Cold Storage/Holding" CCP were inadequate, lacking specifics on how to correct the cause of deviations or ensure potentially adulterated products do not enter commerce. 3. **Failure to maintain sanitation control records (21 CFR 123.11(c)):** The firm lacked