FDA WARNING_LETTER - International Golden Foods Inc - July 20, 2021

The FDA inspected a repackaging and storage facility at 819 Industrial Dr., Bensenville, IL, from June 29 to July 20, 2021, finding serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117). The facility repackages ready-to-eat (RTE) and non-RTE foods and stores RTE cheeses and pre-packaged foods.

Key violations include: 1. **No Food Safety Plan (21 CFR 117.126(a)(1)):** Failure to prepare and implement a comprehensive food safety plan, including hazard analysis, preventive controls, supply-chain program, recall plan, monitoring procedures, corrective action procedures, and verification procedures. 2. **Inadequate Hazard Analysis (21 CFR 117.130(a)):** Failure to identify and evaluate known or foreseeable hazards, specifically: * Environmental pathogens (e.g., Salmonella) for RTE foods exposed to the environment. * Undeclared allergens (e.g., tree nuts, wheat). * Allergen cross-contact, as products with and without allergens are repackaged on the same equipment. 3. **No Preventive Controls (21 CFR 117.135(a)(1)):** Failure