FDA 483 - Nanchang Anobri Pharmaceutical CO., LTD - November 21, 2023

During an inspection conducted from November 13-21, 2023, the U.S. Food and Drug Administration (FDA) identified significant manufacturing quality control issues at Nanchang Anobri Pharmaceutical CO., LTD. The inspection revealed that the company's Quality Control Unit (QCU) did not fully adhere to its established responsibilities and procedures, as required by regulatory framework 21 CFR 211.22(d).

Specifically, the QCU failed to adequately review critical analytical data, including High-Performance Liquid Chromatography (HPLC) results for stability studies. This included overlooking deficient peak integrations and the omission of raw data calculations for individual impurities in analytical worksheets. Furthermore, the QCU did not review executed batch records for application drug products and a Media Fill Simulation batch record. These failures raise concerns about the accuracy of impurity test results.

Additionally, the firm failed to consistently follow its own standard operating procedure for integration during laboratory control activities, further evidencing lapses in quality assurance. Nanchang Anobri Pharmaceutical is required to address these observations by implementing comprehensive corrective actions to ensure compliance with good manufacturing practices and prevent recurrence of similar issues. A detailed response outlining these actions should be submitted to the FDA.