FDA 483 - Linhai Tianyu Pharmaceutical Co., Ltd. - September 15, 2023

Linhai Tianyu Pharmaceutical Co., Ltd. in Taizhou, China, an API and intermediate manufacturer, was cited for significant deficiencies during an FDA inspection. Observations included inadequate cleaning procedures, poor facility and equipment maintenance, and scientifically unsound investigations into out-of-specification results. Additionally, the firm failed to maintain contemporaneous laboratory records, lacked a proper stability testing program, and exhibited insufficient controls over computerized systems and quality control unit oversight.