FDA WARNING_LETTER - Ipswich Shellfish Co., Inc. - September 21, 2012

The FDA inspected Ipswich Shellfish Co., Inc., a seafood processor and importer, from September 11-21, 2012, identifying serious violations of seafood HACCP (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110) regulations. These failures render the firm's fish and fishery products, including imported live lobsters, cooked lobstermeat, smoked salmon, and raw scallops/trout fillets, adulterated. Domestic violations include the absence of HACCP plans for raw sea scallops and trout fillets to control Clostridium botulinum toxin, and inadequate critical limits in the HACCP plan for cooked ready-to-eat lobstermeat regarding pathogenic bacterial survival during cooking and cooling. The firm's HACCP plan for reduced oxygen packaged smoked salmon also had an inadequate monitoring procedure/frequency at the receiving CCP, and the firm failed to implement its own monitoring procedures for this product. Further deficiencies included improper storage and disposal of rubbish and offal (21 CFR 110.37(f)), and insufficient monitoring of sanitation to prevent cross-contamination, with raw materials stored directly on floors and exposed packaging. As an importer, the firm failed to implement affirmative steps for imported fishery products, lacking documentation of periodic testing (21 CFR 123.12(a)(2)(ii)). The FDA requires a written response within 15 working days detailing corrective actions and supporting documentation. Failure to comply may result in refusal of admission, detention, seizure, injunction, and re-inspection fees.