FDA 483 - Tianjin Tianyao Pharmaceuticals Co., Ltd. - September 02, 2016

Tianjin Tianyao Pharmaceuticals Co., Ltd. in Tianjin, China, was inspected regarding its API manufacturing operations. The inspection revealed significant deficiencies across data integrity, water system monitoring, stability testing, cleaning validation, OOS investigations, and documentation practices. These issues indicate a lack of robust quality control and data management systems.