FDA WARNING_LETTER - Sea Fex, Inc. dba Seafood Express - March 31, 2014

On May 1, 2014, the FDA issued a Warning Letter to Sea Fex, Inc. dba Seafood Express following an inspection from March 26-31, 2014. The inspection revealed serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110), rendering their seafood products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate HACCP Plan Monitoring:** The HACCP plan for RTE Canned Refrigerated Pasteurized Crabmeat had an insufficient monitoring procedure at the "Receiving" CCP to control *Clostridium botulinum* toxin formation. 2. **Lack of Sanitation Control Records:** The firm failed to maintain monthly sanitation monitoring records for water safety, food contact surface cleanliness, and prevention of cross-contamination, with records not updated since August 2012. 3. **Failure to Implement Monitoring Procedures:** The firm did not follow monitoring procedures for third-party certificates for aquaculture drug hazards in Farm Raised Rainbow Trout and Barramundi, a repeat violation from 2008 and 2010 inspections. The revised HACCP plan for these products appeared copied and inadequate. 4. **Inappropriate Corrective Actions:**