FDA WARNING_LETTER - Evangel International Foods LLC - May 09, 2014

The FDA inspected Evangel International Foods, Inc.'s seafood processing facility from April 28 to May 9, 2014, and found serious violations of seafood HACCP (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110) regulations. The firm's dried catfish products were deemed adulterated.

Key violations include: 1. **Inadequate HACCP Plan (21 CFR 123.6(a) and (c)(2)):** The dried fish HACCP plan lacked critical control points (CCPs) for cooking and drying steps to control pathogen hazards, despite the product being fully cooked in appearance. The firm's response to the FDA 483 indicated a consultant was hired for a temperature study and HACCP plan revision, but no interim pathogen control measures were detailed. 2. **Insufficient Monitoring Procedures (21 CFR 123.6(c)(4)):** Monitoring procedures for metal inclusion at the raw fish cutting CCP and undeclared allergens at the finished product labeling CCP were inadequate. 3. **Failure to Implement Record Keeping (21 CFR 123.6(b) and (c)(7)):** The firm did not record monitoring observations at the labeling CCP for allergen declaration or storage temperature. 4. **Inappropriate Corrective Actions (21 CFR 123.7(b)):