FDA 483 - Livzon New North River Pharmaceutical Co., Ltd. - December 20, 2024

An FDA inspection of Livzon New North River Pharmaceutical Co., Ltd. identified significant deficiencies within its Quality Unit. The firm failed to adequately review and approve complete method validations for final product release, stability testing, and raw materials, and did not ensure appropriate testing of materials, particularly recovery solvents. Furthermore, the Quality Unit failed to investigate critical deviations related to retrospective analyses of method validations.