FDA 483 - K.C. Pharmaceuticals, Inc - February 13, 2023

K.C. Pharmaceuticals, Inc. in Pomona, CA, was inspected for its sterile drug product manufacturing operations. The inspection revealed significant deficiencies across multiple areas, including inadequate process validation, environmental controls, cleaning procedures, and complaint handling. Additionally, issues were noted with laboratory record review, sterilization process validation, test method specificity, and quality control unit procedures, indicating a broad lack of adherence to current Good Manufacturing Practices.