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, requested by the Center for Drug Evaluation and Research (CDER), followed Compliance Program 7356.00F and ICH Q7 guidelines, covering all six quality systems. The company's products intended for the US market are subject to the adulteration provisions of the Food, Drug, and Cosmetic (FD&C) Act.This inspection identified critical deficiencies, resulting in an "Official Action Indicated (OAI)" classification and a recommendation for a warning letter. Key issues included the firm's failure to extend investigations to other potentially affected batches following a failure or deviation. Furthermore, there was a lack of thorough review for unexplained discrepancies or components failing to meet specifications. Inadequate cleaning and maintenance of equipment and utensils also posed a risk of contamination, potentially impacting drug product safety, identity, strength, quality, or purity.These findings echo concerns from a previous OAI inspection in 2019, which cited issues such as insufficient investigation records, unclear contract laboratory responsibilities, deficient cleaning and process validation, and poor facility maintenance. The current inspection confirmed that the quality unit still has not adequately addressed potential impurities in the manufacturing process. The company is required to implement comprehensive corrective actions to resolve these persistent quality system failures and ensure compliance with regulatory standards.