FDA WARNING_LETTER - Derek and Constance Lee Corporation (d.b.a. Great River Food) - September 25, 2012

The FDA conducted an inspection of Derek and Constance Lee Corporation d.b.a. Great River Food in San Francisco, CA, from September 18-25, 2012. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110). Specifically, the firm failed to have and implement a written HACCP plan for its refrigerated, vacuum-packed, ready-to-eat Fried Fish Cakes and Fish Balls. This plan is required to control food safety hazards such as pathogen growth and toxin formation, including Clostridium botulinum toxin, as mandated by 21 CFR 123.6(a) and (b). Consequently, these products are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, having been prepared or held under insanitary conditions that may render them injurious to health. The FDA requires a written response within fifteen working days detailing specific corrective actions, including supporting documentation like HACCP and verification records. Failure to promptly correct these violations could result in further regulatory actions, including product seizure, injunctions against the firm's operations, and the assessment of re-inspection fees to cover FDA's costs.