FDA 483 - Tianjin Tianyao Pharmaceuticals Co., Ltd. - May 24, 2019

An FDA inspection of Tianjin Tianyao Pharmaceuticals Co., Ltd, an API manufacturer in Tianjin, China, revealed significant deficiencies in laboratory controls and equipment maintenance. Observations included inadequate investigation of system suitability deviations, presence of particles in manufacturing equipment, and insufficient analytical procedures for starting materials and method validation for forced degradation studies. These issues suggest a lack of robust quality control and manufacturing oversight.