FDA 483 - K.C. Pharmaceuticals, Inc - August 28, 2024

An FDA inspection of K.C. Pharmaceuticals, Inc. in Pomona, CA, a manufacturer of sterile drug products, revealed significant deficiencies across multiple quality systems. Observations included failures in quality control unit responsibilities, inadequate stability testing, insufficient aseptic process validation, uncontrolled access to labeling materials, and unreviewed laboratory records. Additionally, the firm's water purification system validation was found to be inadequate, indicating a broad pattern of non-compliance with GMP regulations.