FDA WARNING_LETTER - Fish Brothers, Inc. - August 13, 2010

On August 10-13, 2010, the FDA inspected Fish Brothers, Inc. and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice regulation (21 CFR Part 110). Consequently, their refrigerated vacuum packaged hot-smoked seafood products, including Chum Salmon and Albacore Tuna, are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Key violations include inappropriate corrective action plans within their HACCP plans for controlling pathogen growth, C. botulinum toxin formation, and histamine formation, failing to comply with 21 CFR 123.7(b). Specifically, corrective actions for cooking, thawing, and brining critical control points were inadequate, not addressing time parameters, proper temperature monitoring, or ensuring the cause of deviations would be corrected. Additionally, the firm failed to monitor sanitation conditions and practices with sufficient frequency, as required by 21 CFR 123.1(b). This included improper labeling, storage, and use of toxic compounds (e.g., unlabeled sanitizer bottles, using sanitizer on utensils against manufacturer instructions, incorrect dilution), and inadequate exclusion of pests (live and dead flies, spider webs) from processing, packaging, and raw ingredient storage areas. The FDA acknowledged the firm's August 18, 2010 response but found it inadequate, lacking revised HACCP plans or monitoring records. The firm must respond within fifteen working days with specific corrective actions and supporting documentation to avoid further action, such as product seizure or injunction.