Euro International Foods, Inc. – FDA Warning Letter, Mar 1, 2011

On May 27, 2011, the FDA issued a Warning Letter to Euro International Foods, Inc. following inspections on February 25 and March 1, 2011. 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).

Specifically, the firm's refrigerated, vacuum-packaged cold smoked mackerel was deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 342(a)(4)] because it was prepared, packed, or held under insanitary conditions. The primary violation cited was the firm's failure to have and implement a written HACCP plan for this product to control the food safety hazards of *Clostridium botulinum* toxin and scombrotoxin (histamine) formation, as required by 21 CFR 123.6(a) and (b).

The FDA warned that failure to promptly correct these violations could result in further action, including product seizure and/or injunction against the firm's operation. Euro International Foods, Inc. was required to respond in writing within fifteen working days, outlining specific corrective actions, including documentation such as HACCP and verification records. The letter also emphasized the firm