FDA 483 - Sichuan Deebio Pharmaceutical Co., Ltd. - September 08, 2023

Sichuan Deebio Pharmaceutical Co. Ltd. in Guanghan, China, was cited for significant deficiencies in laboratory controls, quality unit responsibilities, and production processes during an FDA inspection. The observations highlight issues with data integrity, inadequate investigations, and a lack of validated procedures for manufacturing, cleaning, and distribution of active pharmaceutical ingredients. These findings indicate a serious lack of control over critical aspects of drug substance quality and compliance.