FDA WARNING_LETTER - Pt Dua Kelinci - August 23, 2023

The FDA inspected a ready-to-eat (RTE) confectionaries and snack foods manufacturing facility in Pati, Indonesia, from August 22-23, 2023, and found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117). The FDA determined the RTE food products were adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions.

Key violations included: 1. **Failure to maintain a clean and sanitary plant and properly clean/sanitize utensils/equipment (21 CFR 117.35(a)):** Observed visibly dirty water for washing, lack of sanitizer use, and employees using dirty rags to wipe "clean" items. 2. **Inadequate cleaning frequency for allergen cross-contact and contamination (21 CFR 117.35(d)):** The facility manufactures products with various allergens but does not use dedicated lines or clean between allergen-containing products, only at shift end. Observed dirty spatulas, transfer bags, and bins used for in-process products. 3. **Failure to clean non-food contact surfaces adequately (21 CFR 117.35(e)):** Observed visible food debris and significant residue buildup on wafer machines, mixers, and coating/fryer equipment.