FDA WARNING_LETTER - Wrapers Kitchen - July 29, 2011

On July 22, 28-29, 2011, the FDA inspected Wrapers Kitchen, located at 4120 Brighton Boulevard, Suite B-35, Denver, Colorado, and found violations of the seafood Hazard Analysis and Critical Control Points (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110).

The firm's Creamy Cheese Rangoon product was deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §342(a)) because it was prepared, packed, or held under insanitary conditions that could render it injurious to health.

The primary violation cited was the firm's failure to conduct a hazard analysis and implement a written HACCP plan for Creamy Cheese Rangoon, as required by 21 CFR 123.6(a) and (b). Specifically, the firm lacked controls for pathogen growth and toxin formation from *Clostridium botulinum*, and for major food allergens at the labeling step.

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. Wrapers Kitchen was required to respond in writing within fifteen working days, outlining specific corrective actions, including documentation such as a HAC