JC's Fish & BBQ Inc. – FDA Warning Letter, Feb 8, 2012

On May 1, 2012, the FDA issued a Warning Letter to JC’s Fish & BBQ, Inc. following an inspection from February 6-8, 2012, at their seafood processing facility in Knoxville, Arkansas. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their spoonbill roe adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate HACCP Plan (21 CFR 123.6(a) and (c)(2)):** The firm's HACCP plan for spoonbill roe failed to list finished product refrigerated storage as a critical control point (CCP) for controlling pathogens, including *Clostridium botulinum*. 2. **Insufficient Monitoring Procedures (21 CFR 123.6(c)(4)):** The HACCP plan's monitoring procedures and/or frequencies at a specific CCP were inadequate to control pathogens. Specifically, the critical limit for pathogens in finished product was monitored by "Send sample in for test (b)(4)," while FDA recommends (b)(4) analysis on (b)(4) of finished product. 3. **Inappropriate Corrective Actions (21 CFR 123.7(b)):**