D & N Foods Processing Co., LTD. – FDA Warning Letter, Apr 8, 2014

On April 7-8, 2014, the FDA inspected D & N Foods Processing Co., LTD. in Danang City, Vietnam, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm's ready-to-eat frozen vacuum packaged fried fish cake, fish cake, and imitation crab meat were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

The firm's July 15, 2014, response and revised HACCP plan (July 19, 2014) were inadequate. Key deficiencies included: 1. **Incomplete Hazard Analysis:** The HACCP plan for fried fish cake, fish cake, and imitation crab meat failed to list undeclared food allergens as a reasonably likely food safety hazard (21 CFR 123.6(a) and (c)(1)). 2. **Missing Critical Control Points (CCPs):** The revised HACCP plan did not include CCPs for controlling pathogenic bacteria growth and toxin formation related to: * Cooling following pasteurization to control post-pasteurization recontamination (21 CFR 123.6(a) and (c)(2)). * Container integrity testing after pasteurization to prevent reintroduction of pathogenic bacteria through