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Talk to a SpecialistTalk to a SpecialistK.C. Pharmaceuticals Inc. was cited for significant Current Good Manufacturing Practice (CGMP) violations in the production of sterile drug products at its Pomona, California facility following inspections in January and February 2023. The company failed to establish and follow adequate written procedures to prevent microbiological contamination of sterile drugs, specifically because smoke studies validating aseptic and sterilization processes were inadequate and did not simulate actual manufacturing conditions. Notably, the firm began commercial manufacturing on its aseptic filling line in 2020 without performing adequate smoke studies, and acknowledged that a September 2022 smoke study was insufficient, requiring a repeat study in December 2022. These control deficiencies rendered the drug products adulterated under the Federal Food, Drug, and Cosmetic Act.