FDA WARNING_LETTER - Happy Crab Seafood Inc - January 21, 2011

On January 12, 19, and 21, 2011, the FDA inspected a seafood processing facility in Portland, Oregon, and found serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice regulation (21 CFR Part 110). These violations render the firm's crab meat adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate HACCP Plan (21 CFR 123.6(a) and (c)(2)):** The HACCP plan for "Cooked crabmeat from live crab processed at our plant" fails to list critical control points for cooking (pathogen survival) and cooling (pathogen growth/toxin formation). Critical limits, such as cook cycle length, visual confirmation of rolling boil, initial crab temperature, and batch size, were not adequately defined. 2. **Insufficient Monitoring Procedures (21 CFR 123.6(c)(4)):** HACCP plans for both "Crabmeat processed from cooked, frozen crab sections shipped to us from cannery" and "Cooked crabmeat from live crab processed at our plant" had inadequate monitoring frequencies for "Pathogen Growth due to Temperature Abuse" at the "Meat Processing" and "Icing