FDA WARNING_LETTER - Chung's and Son Company - December 30, 2011

On December 15, 19, 22, and 30, 2011, the FDA inspected Chung's and Son Company's seafood processing facility. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). The firm's vegetable and shrimp egg rolls were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) due to insanitary conditions.

Key violations included the absence of a HACCP plan for ready-to-eat shrimp egg rolls to control hazards like pathogen growth, toxin formation, allergen declaration, and metal inclusion. The firm also failed to adequately monitor sanitation conditions, specifically regarding food contact surfaces and prevention of cross-contamination, citing instances of improper cooling of cooked shrimp.

Additionally, the firm's Vegetable Egg Roll and Shrimp Egg Roll products were found to be misbranded under Section 403 of the Act and 21 CFR Part 101. Misbranding issues included: * Failure to completely or accurately declare the major food allergen shrimp. * Failure to declare all ingredients, including shrimp in the Shrimp Egg Roll, vermicelli rice noodles and their sub-ingredients in the Vegetable Egg Roll, and proper declaration of fats/oils