Changzhou Maokang Medical Products Co., LtdAugust 24, 2018

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

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Record Details

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.

Company: Changzhou Maokang Medical Products Co., Ltd
Inspection Date: August 24, 2018
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Niketa Patel (Consumer Safety Officer/ORA/OMPTO/TOS)

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