FDA WARNING_LETTER - Thaveevong Industry Co., Ltd. - May 10, 2013

On November 26, 2013, the FDA issued a Warning Letter to Thaveevong Industry Co., Ltd, following an inspection from May 7-10, 2013, at their seafood processing facility in Samut Sakhon, Thailand. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their cooked ready-to-eat products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

The firm's response to the FDA-483, submitted via email on May 24, 2013, including hazard analyses and four HACCP plans, was deemed inadequate. Specific deficiencies included: 1. Failure to list *Clostridium botulinum* toxin formation as a food safety hazard in their HACCP plans for vacuum-packaged products, despite observations of products held at ambient temperatures, creating conditions conducive to toxin growth. 2. Failure to list cooling as a critical control point for controlling pathogen growth and toxin formation after cooking, given significant post-cook handling. 3. Failure to list labeling as a critical control point for controlling undeclared allergens. 4. Inadequate corrective actions for deviations at the steaming critical control point, as the plan did not address correcting the cause of the deviation (e.g.,