FDA WARNING_LETTER - Center Oriental Food - May 15, 2008

On May 13 and 15, 2008, the FDA inspected a food and seafood processing facility at 9641 15th Avenue SW, Seattle, Washington, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation for foods (21 CFR Part 110).

The seasoned dried anchovy produced by the firm was deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 342(a)(4)) because it was prepared, packed, or held under insanitary conditions.

Key violations included: 1. **Lack of HACCP Plan:** The firm failed to have and implement a written HACCP plan for seasoned dried anchovy to control food safety hazards such as pathogen growth, potential toxin production, and undeclared food allergens (specifically wheat), violating 21 CFR 123.6(a) and (b). 2. **Insufficient Sanitation Monitoring:** The firm did not sufficiently monitor sanitation conditions and practices, violating 21 CFR 123.11(b). Examples included: * An inaccessible handwashing sink due to blocking barrels (21 CFR 123.11(b)(4)).