FDA WARNING_LETTER - Hong Kong Food Co. - September 01, 2011

On October 11, 2011, the FDA issued a Warning Letter to Hong Kong Food Co. following an inspection from August 16 to September 1, 2011, at their Los Angeles facility. 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 FDA determined that the company's vacuum-packaged fish ball, shrimp ball, "cuttlefish" ball, and fish paste products are adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions.

Key violations included: 1. **Lack of Critical Control Point (CCP):** The HACCP plan for Fresh and Frozen Fish Balls lacked a CCP to control *Clostridium botulinum* growth and toxin production in refrigerated products. 2. **Insufficient Monitoring Procedures:** The HACCP plan's monitoring frequency for CCP #4 (Storage) was inadequate for *Clostridium botulinum* control, with visual temperature checks only during operational periods, failing to cover overnight or extended non-operational times. 3. **Incomplete Hazard Analysis:** The HACCP plan for Fresh and Frozen Fish Balls did not list undeclared allergens (fish proteins,