FDA 483 - K.C. Pharmaceuticals, Inc - February 13, 2026

An FDA Form 483 was issued to K.C. Pharmaceuticals, Inc. following an inspection that revealed significant deficiencies across multiple areas of their manufacturing operations. The observations highlight critical issues with aseptic processing validation, quality control unit responsibilities, data integrity, batch record completeness, and contamination prevention, indicating a broad lack of adherence to good manufacturing practices.