FDA WARNING_LETTER - Clark Seafood Co, Inc - April 12, 2013

On April 10-12, 2013, an FDA inspection of Clark Seafood Company, Inc. in Pascagoula, Mississippi, revealed significant deviations from seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR 123) and Current Good Manufacturing Practices (CGMP) (21 CFR 110). These violations render all seafood products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).

Key violations include: 1. Failure to have a written HACCP plan for fresh fish (Amberjack) to control scombroid toxin formation due to time/temperature abuse, lacking monitoring and records for transit, cooler, and freezer temperatures. 2. Failure to monitor sanitation conditions, specifically no well water testing for water contacting food or used for ice (21 CFR 123.11(b)). 3. Lack of required HACCP training or qualification through job experience for an employee (21 CFR 123.10). 4. Failure to maintain sanitation control records for water safety, food contact surfaces, cross-contamination prevention, handwashing/toilet facilities, food protection, chemical labeling/storage, employee health, and pest exclusion (21 CFR 123.11(c)). 5. Failure to remove litter, waste, and cut weeds/grass