FDA WARNING_LETTER - Vince & Sons Pasta Company - March 06, 2012

The FDA inspected Vince & Sons Pasta Company's facility in Bridgeview, Illinois, on February 14 and March 06, 2012, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm's vacuum-packaged lobster product is deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as it was prepared, packed, or held under unsanitary conditions.

Key violations include: 1. **Lack of a written HACCP plan:** The firm does not have a HACCP plan for vacuum-packaged lobster to control the hazard of *C. botulinum* growth, violating 21 CFR 123.6(b). 2. **Lack of HACCP-qualified personnel:** No one associated with the firm has completed the required HACCP training or is HACCP qualified through job experience, violating 21 CFR 123.10. Firm management is unfamiliar with seafood-associated hazards.

The FDA warns that failure to promptly correct these violations may lead to further action, including product seizure and/or injunction against the firm's operation. Vince & Sons Pasta Company must respond in writing within fifteen working days, outlining specific corrective actions, including documentation such as HACCP and verification records. The letter also emphasizes the firm's responsibility