FDA WARNING_LETTER - J. DeLuca Fish Company, Inc. - September 01, 2011

On December 9, 2011, the FDA issued a Warning Letter to J. DeLuca Fish Company, Inc. following an inspection that concluded on September 1, 2011. 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 regulation (21 CFR Part 110). These violations render the firm's fish and fishery products 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 include: 1. **Inadequate HACCP Plan Critical Limits:** The firm's HACCP plan for "Histamines" at the "Receiving" Critical Control Point (CCP) lists critical limits related to onboard handling, which are insufficient for a primary processor receiving fish directly from harvest vessels. The plan should include sensory examination of fish and adequate internal temperature monitoring at receiving. 2. **Inadequate HACCP Plan Monitoring Procedures:** * At the "Receiving" CCP, the monitoring procedure for "Harvest vessels records and receiving fish temperature" lacks detail on how these will be monitored (e.g., visual review, thermometer use, number of fish measured). * At the "Storage" CCP, monitoring cooler temperatures "periodically" during