Wild Edibles Inc. – FDA Warning Letter, Sep 12, 2014

On September 10 and 12, 2014, the FDA inspected Wild Edibles, Inc.'s seafood processing facility and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice (CGMP) regulation for foods (21 CFR Part 110). These violations render products like marinated anchovies, smoked salmon, pasteurized canned crab, and histamine species (yellowfin tuna, mahi mahi, bluefish, mackerel) adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).

Key violations include: 1. **Lack of HACCP Plans:** No HACCP plans for refrigerated ready-to-eat products (marinated anchovies, smoked salmon, pasteurized canned crab meat, whitefish salad, smoked salmon salad) to control hazards like undeclared allergens, pathogen growth, and toxin formation (e.g., *Clostridium botulinum*). 2. **Incomplete Hazard Analysis:** The HACCP plan for yellowfin tuna, mahi mahi, bluefish, and mackerel failed to list parasites as a food safety hazard for raw (not frozen) mackerel. 3. **Inadequate Monitoring Procedures:** The HACCP plan for histamine species lacked adequate monitoring procedures for critical control points related to pathogen growth and scombrotoxin (hist