FDA WARNING_LETTER - third synthesis inc., - March 24, 2022

The FDA inspected a bakery facility at 5569 N. Northwest Highway, Chicago, IL, from February 24 to March 24, 2022, with a follow-up on May 3, 2022. The inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117), leading to the determination that ready-to-eat (RTE) cakes and paczkis were adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).

Key violations include: 1. **Inadequate Hazard Analysis and Preventive Controls (21 CFR Part 117, Subpart C):** * Failure to appropriately evaluate undeclared allergens as a significant hazard requiring preventive controls, despite a recall on February 25, 2022, for undeclared wheat, milk, and/or egg in paczkis and coffee cakes. The allergen control program lacked adequate monitoring frequency and implementation. * Failure to adequately control allergen cross-contact. The hazard analysis incorrectly determined allergen cross-contact did not require a preventive control based on the Sanitation SOP. The allergen control program was insufficient, lacking monitoring/verification and not addressing all food-contact equipment or distinguishing between products with different allergen profiles. Observations included cross-