FDA WARNING_LETTER - VAN Oriental Food, Inc - May 16, 2014

An FDA inspection of Van Oriental Food, Inc.'s seafood processing facility in Dallas, TX, from April 23 to May 16, 2014, revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). Consequently, the firm's shrimp egg rolls are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Key violations include the failure to have a HACCP plan that lists critical control points (CCPs) for controlling pathogen growth and toxin formation during the cooking of egg rolls, particularly for products appearing fully cooked, as required by 21 CFR 123.6(a) and (c)(2). Additionally, the firm's HACCP plan for retail egg rolls lacked adequate critical limits (CLs) to control identified hazards, as mandated by 21 CFR 123.6(c)(3). The listed critical limit for internal product temperature was insufficient without a corresponding holding time, and the supporting lethality study was found to be inadequate. The FDA recommends conducting temperature distribution and heat penetration studies to validate cooking processes. The firm must respond in writing within fifteen working days, outlining specific corrections, providing supporting documentation, and addressing any delays. Failure to correct these violations could lead to product seizure, injunction, and re-inspection fees.