FDA WARNING_LETTER - Central Boeki California Ltd - June 15, 2015

On September 8, 2015, the FDA issued a Warning Letter to Central Boeki California, Ltd. following an inspection from June 12-15, 2015. 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).

Key violations include: 1. **Lack of HACCP Plans:** The firm failed to have and implement written HACCP plans for refrigerated Baked Sardines, Baked Goby, and Fish Sausage to control pathogen growth and toxin formation. Additionally, these products, labeled "KEEP REFRIGERATED," were found stored at ambient temperature. The firm's submitted HACCP plan was deemed inadequate due to a lack of employee training documentation and CCP monitoring records. 2. **Inadequate Sanitation Records:** The firm did not maintain sanitation monitoring records for hand washing, hand sanitizing, toilet facilities, protection of food/packaging/contact surfaces, proper labeling/storage/use of toxic chemicals, and pest exclusion for refrigerated Baked Sardines, Baked Goby, Fish Sausage, and frozen Jack Mackerel. The submitted SSOP was insufficient without training documentation and recent monitoring records. 3. **Insufficient Importer Verification:** As an importer, the firm lacked written verification procedures, product specifications, and an affirmative step to ensure imported fish (specifically (b