FDA WARNING_LETTER - Capitol Foods, Inc. - March 27, 2012

The FDA inspected Capitol Foods, Inc., a multiple food warehouse and ready-to-eat (RTE) shrimp egg roll manufacturer, from March 19-27, 2012. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123) and food labeling regulations (21 CFR 101), rendering their fish and fishery products adulterated and misbranded. Key HACCP violations included the firm's failure to conduct a hazard analysis and implement a written HACCP plan for RTE shrimp egg rolls to control pathogen growth, toxin formation, and undeclared allergens, as required by 21 CFR 123.6(a) and (b). Additionally, the firm did not maintain sanitation control records for various critical areas, violating 21 CFR 123.11(c). Labeling deficiencies for the Shrimp Egg Roll product included adulteration due to the undeclared presence of FD&C Yellow No. 5, making it unsafe under section 402(c) and 721(a) of the Act. The product was also misbranded under section 403(k) for failing to declare certified color additives (FD&C Yellow #5 and #6) and under section 403(w) for not accurately declaring the major food allergen, wheat. Furthermore, the label failed to declare all ingredients and sub-ingredients by their common or usual names, violating section 403(i)(2) and 21 CFR 101.4(b). The FDA also noted issues with quantity of contents declaration and foreign language requirements. Capitol Foods, Inc. must promptly correct these violations, including developing and implementing a HACCP plan, maintaining sanitation records, and revising product labels. A written response detailing corrective actions and supporting documentation is required within fifteen working days. Failure to comply may result in product seizure or injunction.