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Talk to a SpecialistTalk to a SpecialistJost Chemical Co., an active pharmaceutical ingredient (API) manufacturer, was cited for significant current good manufacturing practice (CGMP) violations that rendered their APIs adulterated. FDA inspectors found that the company's quality unit failed to adequately investigate and resolve quality-related complaints and out-of-specification results, including a 2018 mold contamination incident in Potassium Sulfate lots where the company did not initiate a formal recall or sufficiently expand investigations to identify all potentially affected batches. The inspection, conducted January 10-21, 2022, revealed that the company's methods, facilities, and controls for manufacturing, processing, packing, and holding did not conform to required regulatory standards under the Federal Food, Drug, and Cosmetic Act.