FDA WARNING_LETTER - Riddle Brothers - March 12, 2012

On March 2 and 12, 2012, the FDA inspected Riddle Brothers' seafood processing facility in Hornbeak, Tennessee, finding serious violations of seafood HACCP (21 CFR 123) and CGMP (21 CFR 110) regulations. The firm's Paddlefish, Sturgeon, or Bowfin roe product is deemed adulterated.

Key violations include: 1. **Failure to take appropriate corrective action:** The firm did not take corrective action when Paddlefish, Sturgeon, or Bowfin roe deviated from the critical limit for water phase salt at the Salt Processing CCP on June 7, 2010, risking *Clostridium botulinum* growth. The documented corrective action plan was also deemed inappropriate. 2. **Failure to implement monitoring procedures:** The firm did not follow the specified monitoring procedure for water phase salt at the Salt Processing CCP, with the last analysis recorded on June 7, 2010. 3. **Failure to implement record-keeping system:** The firm did not maintain records for annual calibration of temperature recording devices, as required by their HACCP plan. 4. **Failure to monitor sanitation conditions:** The firm lacked sanitation records for water safety, handwashing/toilet facilities, protection from contaminants, toxic chemical labeling/storage, and pest exclusion. Additionally, the facility grounds had improperly stored equipment, litter, and untrimmed vegetation,