FDA WARNING_LETTER - Dixon Fisheries Inc - August 15, 2017

On August 8-15, 2017, the FDA inspected Dixon Fisheries, Inc. and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm's cheesy crab spread and scallop and shrimp macaroni salad products were deemed adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions.

The firm failed to submit a formal response to the FDA-483 issued on August 15, 2017.

Key violations include: 1. **Inadequate Hazard Analysis and HACCP Plan (21 CFR 123.6(a) and (c)(1)):** The HACCP plans for cheesy crab spread and scallop and shrimp macaroni salad did not list *Clostridium botulinum* growth and toxin formation as a reasonably likely hazard, despite products being in reduced oxygen packaging. Additionally, major food allergens (milk, wheat, eggs, fish) present in these products were not included as food safety hazards in the HACCP plans. 2. **Missing Monitoring Frequencies (21 CFR 123.6(c)(4)):** The HACCP plans lacked monitoring frequencies for critical control points (thaw, preparation, holding) to control bacterial growth and survival for crab flakes, scallop, and shrimp. 3. **In