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

This FDA Form 483 details observations from an inspection, citing multiple deficiencies in the facility's quality system, laboratory controls, document controls, and personnel training.

**Quality System:** The Quality Unit failed to fully follow responsibilities and procedures, specifically by not reviewing HPLC chromatograms (deficient peak integrations) and calculations for individual impurities in stability studies, and by omitting raw data calculations in analytical worksheets. They also failed to review executed batch records for application drug products and Media Fill Simulation batch records, potentially impacting the accuracy of impurity test results. This violates 21 CFR 211.22(d).

**Laboratory Control System:** Established test procedures and laboratory control mechanisms were not followed. Deficient peak integrations were observed in chromatograms, contrary to SOP # 01/02/02-047-01. Additionally, the Microbial count SOP # 01/04/10-017-03 lacked specific instructions for complete examination of microbial plates, including details on evaluating overlapping colonies, counting mold and yeast, light usage during examination, second check analyst confirmation, and analyst re-qualification for bacterial counting technique effectiveness.

**Document Controls:** Document control procedures (QP-001-05, QP-002-03) were not adequately established or maintained. They failed to include steps for designating the issuance of pre-numbered quality system records (e.g., temperature monitoring logs, CAP