FDA WARNING_LETTER - Tico's Mexican Foods, inc. - September 27, 2010

The FDA inspected Tico's Mexican Foods, Inc. from September 21-27, 2010, and found serious deviations from the Seafood Hazard Analysis and Critical Control Points (HACCP) Regulation (21 CFR Part 123). The firm's clam chowder is deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act because it was prepared, packed, or held under insanitary conditions.

The primary violation is the firm's failure to conduct a hazard analysis and implement a written HACCP plan for clam chowder to control potential food safety hazards, specifically pathogen growth and toxin formation (including *Clostridium botulinum*) and allergens, as required by 21 CFR 123.6(a) and (b). The firm's October 11, 2010, response to the FDA 483 was inadequate, as it did not provide a HACCP plan for the product, only stating an intention to write an interim plan and for the General Manager to enroll in training.

The FDA warns that failure to promptly correct these violations may result in regulatory action, including seizure of products or an injunction against the firm. Tico's Mexican Foods, Inc. must respond in writing within 15 working days, outlining specific corrective actions, including providing HACCP plans and supporting documentation such as temperature monitoring records and cook steps