FDA 483 - Changzhou Pharmaceutical Factory - January 12, 2024

Changzhou Pharmaceutical Factory Company Ltd. was inspected and cited for multiple significant deficiencies in its drug and API manufacturing operations. Observations included inadequate equipment cleaning and maintenance procedures, failure to thoroughly investigate discrepancies and report critical deviations, and insufficient visual examination of reserve samples for seal integrity. These issues indicate a lack of robust quality control and adherence to established procedures, potentially impacting product quality and safety.