FDA WARNING_LETTER - Landshire, Inc - September 22, 2011

FDA inspected Landshire, Inc., d/b/a Mom's Food Products Inc., in Fort Worth, Texas, from September 8-22, 2011, and found a serious violation of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123. Specifically, the firm failed to have and implement a written HACCP plan for the manufacturing of Ready-to-Eat Tuna Salad Sandwiches to control the food safety hazard of Clostridium botulinum, as required by 21 CFR 123.6(a) and (b). This renders the Ready-to-Eat Tuna Salad Sandwiches adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. The FDA warned that further action, such as product seizure or injunction, may be taken if the violation is not promptly corrected. The firm was required to respond in writing within fifteen working days, outlining specific corrective actions, including HACCP and verification records. A regulatory meeting was scheduled for January 26, 2012. The letter also reminded the firm of its responsibility to comply with 21 CFR Part 123 and 21 CFR Part 110 (Current Good Manufacturing Practice regulation) and to prevent future violations.