FDA WARNING_LETTER - Chuck's Seafoods, Inc. - August 18, 2009

On August 17-18, 2009, the FDA inspected a seafood processing facility at 91135 Boat Basin Drive, Charleston, Oregon, identifying 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). These violations render the firm's canned Albacore tuna products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate HACCP Plan Monitoring:** The "Albacore Tuna" HACCP plan's "Cooler Temp" Critical Control Point (CCP) monitoring, a daily thermometer check, is insufficient to control histamine formation. FDA recommends continuous monitoring or daily visual checks of ice/cooling media. 2. **Inappropriate Corrective Actions:** The corrective action plan for the "Cooler Temp" CCP is inadequate. It fails to describe steps to correct the cause of deviation and cannot be implemented because the 24-hour monitoring frequency prevents determining if tuna was exposed to temperatures over 40°F for more than 4 hours. 3. **Insufficient Sanitation Monitoring:** The firm did not sufficiently monitor sanitation conditions as required by 21 CFR 123.11(b), evidenced by: * Unlabeled toxic