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

K.C. Pharmaceuticals, Inc., a manufacturer of sterile drug products located in Pomona, CA, was inspected by the FDA from August 19 to August 28, 2024. The inspection revealed several critical compliance issues primarily related to the Quality Assurance (QA) department and documentation control.

Key violations include the failure of the QA department to adhere to written responsibilities and procedures. Specifically, drug product batches were released despite unresolved issues in batch records, such as open investigation reports and deviations from Good Manufacturing Practice (GMP) procedures. Additionally, the QA Document Control group did not maintain adequate control over GMP records, with unlocked storage cabinets accessible to all personnel and the presence of obsolete document copies in the laboratory.

Moreover, the firm's stability testing program was not followed as required. Stability samples were stored in an unmonitored environment for temperature and humidity, and there was a significant delay in placing these samples into appropriate stability chambers, compromising the integrity of the stability testing process.

The FDA requires K.C. Pharmaceuticals to implement corrective actions to address these deficiencies. This includes ensuring that QA responsibilities are clearly documented and followed, securing GMP records, removing obsolete documents, and adhering to the stability testing program. These actions are necessary to comply with regulatory standards and ensure the safety and efficacy of their drug products.