FDA EIR - Zhejiang Tianyu Pharmaceutical Co., Ltd. - March 04, 2022

An FDA inspection of Zhejiang Tianyu Pharmaceutical Co., Ltd., an intermediate and active pharmaceutical ingredient (API) manufacturer, was conducted from February 28 to March 4, 2022. This for-cause inspection, initiated by the Center for Drug Evaluation and Research (CDER), followed Compliance Program 7356.00F for API processes and ICH Q7 guidelines. The firm's products for the US market are subject to the adulteration provisions of the Food, Drug, and Cosmetic (FD&C) Act. The inspection revealed several significant issues, leading to an "Official Action Indicated (OAI)" classification and a warning letter recommendation. Key violations included a failure to extend investigations to other potentially affected batches following specific failures or deviations, and inadequate review of unexplained discrepancies where components did not meet specifications. Furthermore, equipment and utensils were not consistently cleaned or maintained to prevent contamination affecting product safety, identity, strength, quality, or purity. These findings echo concerns from a previous OAI inspection in 2019, which cited deficiencies such as inadequate batch failure investigation records, unclear contract laboratory responsibilities, and insufficient cleaning and process validation. The current inspection indicates the firm's quality unit has not adequately addressed potential impurities in the manufacturing process, highlighting persistent quality system vulnerabilities. The FDA requires the company to implement comprehensive corrective actions to address these recurring and new observations.