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Talk to a SpecialistTalk to a SpecialistSalt City Baking Company manufactured ready-to-eat bread products under insanitary conditions that may have been contaminated with filth or rendered injurious to health, violating Current Good Manufacturing Practice (CGMP) regulations. During a July 2024 inspection, the FDA identified significant failures in hazard analysis and risk-based preventive controls under 21 CFR Part 117, including the company's failure to conduct required hazard analyses for their products. The facility had not responded to the initial FDA Form 483 inspection observations issued at the time of the inspection, prompting this formal warning letter.