FDA WARNING_LETTER - Stonington Sea Products, LLC - January 18, 2013

On February 13, 2013, the FDA issued a Warning Letter to Stonington Sea Products, LLC, following an inspection from January 14-18, 2013. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice (CGMP) regulation (21 CFR Part 110). These violations render the firm's ready-to-eat (RTE) seafood products, including refrigerated RTE crabmeat, adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions.

Key violations include: 1. **Inadequate HACCP Plan Critical Limits:** The HACCP plan for crabmeat cooking listed a timer setting as a critical limit, but the cook record indicated an internal product temperature. Observed internal temperatures were below the recorded target, requiring re-cooking. The firm must validate cooking critical limits to control pathogenic bacteria. 2. **Failure to Implement Record Keeping:** The firm did not consistently record monitoring observations at the cooking critical control point as required by their HACCP plan, with incomplete records noted on multiple dates. 3. **Inadequate HACCP Plan Monitoring Procedures:** The HACCP plan's monitoring procedure for the storage critical control point (visual