FDA WARNING_LETTER - Byron Townsend - November 15, 2012

On November 13-15, 2012, the FDA inspected a seafood processing facility at 266 May Hollow Branch Rd., Tollesboro, KY, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). As a result, the facility's paddlefish roe and meat are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) due to insanitary conditions.

Key violations include: 1. **Inadequate Hazard Analysis:** HACCP plans for paddlefish roe and meat do not list allergens as a food safety hazard, violating 21 CFR 123.6(a) and (c)(1). 2. **Missing Critical Limits:** The paddlefish roe HACCP plan lacks critical limits at the processing (salting) critical control point to control pathogen growth, toxin formation, and *Clostridium botulinum* toxin formation, violating 21 CFR 123.6(c)(3). 3. **Insufficient Monitoring Procedures:** The paddlefish roe HACCP plan's storage monitoring procedure (daily mercury dial thermometer readings) is inadequate for controlling pathogen growth and toxin formation, and the processing (salting) monitoring procedure does not specify how or how frequently salt will be monitored, violating 21