Wilmington Cold Storage, Inc. – FDA Warning Letter, Jan 28, 2008

On February 15, 2008, the FDA issued a Warning Letter to Wilmington Cold Storage, Inc. following an inspection conducted on January 7, 11, 23, and 28, 2008. 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 for foods (21 CFR Part 110).

The primary violation identified was the firm's failure to conduct a hazard analysis and implement a written HACCP plan for refrigerated vacuum packaged surimi to control the food safety hazard of pathogen growth and toxin formation, as required by 21 CFR 123.6(a) and (b). This renders the refrigerated vacuum packaged surimi adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4), due to being prepared, packed, or held under insanitary conditions.

The FDA stated that failure to promptly correct these violations could result in further action, including product seizure and/or injunction against the firm's operations. Wilmington Cold Storage, Inc. was required to respond in writing within fifteen working days, outlining specific corrective actions, including a HACCP plan and verification records. The letter also advised the firm