FDA WARNING_LETTER - Tony & Sons Seafood Corp. - March 19, 2008

On July 18, 2008, the FDA issued a Warning Letter to Tony & Son Seafood Corp. following an inspection from March 12-19, 2008. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110).

The primary violation identified was the firm's failure to have and implement a written HACCP plan for refrigerated ready-to-eat pasteurized crab meat in hermetically sealed containers. This omission is critical for controlling the food safety hazard of pathogen growth and toxin formation, specifically Clostridium botulinum toxin. The FDA considers this product adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

The letter specifies that a proper HACCP plan must include a hazard analysis, critical control points, critical limits, monitoring procedures (e.g., continuous temperature monitoring at or below 40°F during receipt and storage), and recordkeeping activities. Corrective actions must also be appropriate and consistent with monitoring procedures.

Tony & Son Seafood Corp. was required to respond in writing within fifteen working days, detailing corrective actions, including HACCP and verification records. Failure to comply could result in product seizure and/or injunction against the firm's operation. The letter also emphasized the firm'