Hocean Food Corporation – FDA Warning Letter, Dec 1, 2010

On April 13, 2011, the FDA issued a Warning Letter to Hocean Food Corporation following an inspection from November 29 to December 1, 2010. The inspection revealed serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110). These violations render the firm's fishery and non-fishery products, including BANH CUON RICE ROLLED NOODLES with SHRIMP, BANH CUON RICE ROLLED NOODLES, BANH MONG Rice Noodle, and BAHN PHO TUOI Pure Rice Noodle, adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).

Key violations include: 1. **HACCP Plan Deficiency:** The firm lacks a HACCP plan for Rice Noodles with shrimp to control hazards like pathogen survival, undeclared sulfites, and metal inclusion (21 CFR 123.6(a), (b)). The submitted handwritten response was deemed insufficient. 2. **Sanitation Monitoring Failures:** The firm failed to monitor sanitation conditions and practices with sufficient frequency (21 CFR 123.11(b)). Specific issues included uncleanable cooking ladles, a frayed cloth