Chukar Cherry Company – FDA Warning Letter, Nov 28, 2018

The FDA inspected Chukar Cherry Company's chocolate confection facility from November 5-28, 2018, following a consumer complaint and FDA sampling that found elevated milk protein in "Ultra Dark Chocolate Amaretto Rainier cherries," despite milk not being an ingredient. This led to voluntary recalls. The inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR 117), deeming products adulterated under 21 USC § 342(a)(4).

Key violations include: 1. **Preventive Controls:** Failure to identify unintentional milk allergens as a hazard requiring a supply-chain control for bittersweet chocolate, despite supplier warnings. 2. **Reanalysis:** Not reanalyzing the food safety plan after becoming aware of new information (consumer complaint, high milk protein test results). 3. **Supplier Verification:** Not conducting appropriate supplier verification activities, such as annual onsite audits for hazards like Salmonella, E. coli, and milk allergens that could cause serious health consequences. 4. **Implementation of Controls:** Not implementing the "run order of allergenic materials" preventive control, and inadequate allergen controls for rework, leading to potential cross-contact. 5. **Monitoring:** Inadequate monitoring frequency of preventive controls, with observed chocolate residue on equipment and near non-chocolate products. 6. **Documentation:** Failure to document monitoring of preventive controls, specifically visual