Foo Yuan Food Products – FDA Warning Letter, Oct 20, 2014

On October 14, 15, and 20, 2014, the FDA inspected Foo Yuan Food Products Co., Inc.'s seafood processing facility and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). These violations render their fish ball and fish cake products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate Hazard Analysis and HACCP Plan (21 CFR 123.6(a) and (c)(2)):** The "Fish balls" HACCP plan lacks a critical control point for cooking to control pathogen growth and toxin formation. The "Fried Fish Balls" HACCP plan lacks a critical control point for overnight refrigerated storage to control pathogen growth and toxin formation. 2. **Inadequate Critical Limits (21 CFR 123.6(c)(3)):** The "Fried Fish Balls" HACCP plan's cooking critical limit for *Clostridium botulinum* is insufficient to control pathogen growth and toxin formation, specifically *Listeria monocytogenes*. The "Packaging & Labeling" critical limit for both "Fish Balls" and "Fried Fish Balls" relies on consumer cooking, which is inadequate for controlling *Clostridium botulinum* toxin formation in refrigerated, reduced-oxygen packaged products.