FDA WARNING_LETTER - Artisan Specialty Foods - September 22, 2008

On September 18-22, 2008, the FDA inspected Artisan Specialty Foods' seafood processing facility in Lyons, Illinois, and found 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).

Specifically, the firm failed to conduct a hazard analysis and implement a written HACCP plan for anchovy filets to control the food safety hazard of histamine, as required by 21 CFR 123.6(a) and (b). This renders the anchovy filets adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 342(a)(4)), as they were prepared, packed, or held under insanitary conditions.

The FDA warns that failure to promptly correct these violations may result in further action, including product seizure and/or injunction against the firm's operation. Artisan Specialty Foods must respond in writing within fifteen working days, outlining specific corrective actions, including documentation such as HACCP and verification records. If corrections cannot be completed, the firm must explain the delay and provide a timeline for completion. The letter emphasizes the firm's responsibility to ensure full compliance with all applicable regulations and prevent future violations.