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

An FDA inspection of an Active Pharmaceutical Ingredient (API) manufacturer in Qingyuan City, Guangdong Province, P.R. China, revealed significant deficiencies within its Quality System. While specific inspection dates were not provided in the document, the observations highlight a failure of the firm's Quality Unit to uphold core responsibilities crucial for Good Manufacturing Practices (GMP). Key violations include the Quality Unit's failure to adequately review and approve complete method validations. Specifically, critical analytical methods for final product release and stability testing of API batches distributed in the U.S. market were found incomplete, lacking full validation according to the firm's own procedures. Similar issues were identified with methods for testing incoming "key" raw materials, where numerous tests lacked proper validation or verification. Furthermore, analytical methods used for cleaning validation were deficient, failing to evaluate robustness. The inspection also noted a lack of Performance Qualifications, Cleaning Validations, and Method Validations for recovery solvents, alongside insufficient testing for impurities in these recovered materials. The Quality Unit additionally failed to investigate critical deviations, particularly regarding retrospective analyses of method validations that were incomplete or performed past established limits without proper deviation initiation or consistent updates to relevant GMP documents, such as the Master Validation Plan. The company is required to promptly address these observations to ensure full compliance with regulatory standards.