FDA 483 - Changzhou Maokang Medical Products Co., Ltd - August 24, 2018

Changzhou Maokang Medical Products Co., Ltd, a contract manufacturer in Changzhou, China, was cited for significant deficiencies in laboratory record-keeping and drug product release testing. The inspection revealed issues with incomplete electronic data, discrepancies between printed and electronic records, and a lack of proper review procedures for analytical data. Additionally, the firm's testing methods for drug product release were found to be inadequate, failing to ensure conformance to final specifications.