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Talk to a SpecialistTalk to a SpecialistThird Synthesis Inc., doing business as Chicago Sweet Connections Inc., a bakery in Chicago, Illinois, manufactured ready-to-eat cakes and paczkis under insanitary conditions that may have resulted in contamination or rendered products injurious to health, violating Current Good Manufacturing Practice (CGMP) and preventive controls regulations under 21 CFR Part 117. FDA investigators conducting inspections from February through May 2022 identified serious violations including failure to implement required hazard analysis and risk-based preventive controls, resulting in products deemed adulterated. The company also failed to comply with food labeling requirements under Section 403 of the Federal Food, Drug, and Cosmetic Act for certain products manufactured at the facility.