Cerreta Candy Company, Inc. – FDA Warning Letter, Aug 26, 2019

The FDA inspected a ready-to-eat (RTE) candy and snack food manufacturing facility in Glendale, Arizona, from August 19-26, 2019, revealing serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR Part 117). The facility's RTE products were deemed adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions.

Key violations included: 1. **Inadequate Hazard Analysis:** Failure to identify and evaluate all potential hazards for ingredients like crushed peppermint/candy cane, pretzels, ground cinnamon, and honey in RTE products. 2. **Insufficient Environmental Monitoring:** Lack of adequate written procedures for environmental monitoring, with an insufficient number, location, and frequency of sampling sites to verify the effectiveness of sanitation preventive controls for environmental pathogens like Salmonella and potentially *Listeria monocytogenes*. 3. **Failure to Implement Preventive Controls:** Inadequate controls for Salmonella in raw, blanched peanuts, as the supplier's documentation did not confirm Salmonella control, and the facility's roasting process was not validated as a preventive control. 4. **Deficient Supply-Chain Program:** Absence of a risk-based supply-chain program with established verification activities for hazards in tree nuts, raisins, and dried cranberries. 5. **Undocumented