FDA WARNING_LETTER - Onorato & Company, Inc. - August 09, 2011

An FDA inspection of a seafood processing facility in South San Francisco, California, on August 3, 4, 8, and 9, 2011, 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 chilled, histamine-forming fish (Tuna) and refrigerated ready-to-eat canned Dungeness crabmeat adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate HACCP Plans:** * The HACCP plan for "Fresh Fish (histamine Producing...Tuna...)" had an inadequate critical limit at the Receiving CCP to control histamine formation, with FDA recommending specific temperature and transit time controls. * The HACCP plan for "Cooked Crab (various species)...Dungeness crabmeat" had inadequate critical limits at the Receiving CCP and Cooler Storage CCP to control pathogen growth and toxin formation, specifically Clostridium botulinum, with FDA recommending temperatures below 38°F for reduced oxygen packaged products. 2. **Insufficient Monitoring Procedures:** The HACCP plans for both fresh fish and cooked crab products listed inadequate monitoring frequencies for Cooler Storage CCPs to control histamine and pathogen formation, respectively