FDA 483 - Tianjin Tianyao Pharmaceuticals Co., Ltd - May 31, 2019

An FDA inspection of Tianjin Tianyao Pharmaceuticals Co., Ltd in Tianjin, China, revealed significant deficiencies in their manufacturing and laboratory operations. The firm failed to follow established environmental monitoring procedures for its Class D production area and maintained inadequate stability procedures for in-process products. Additionally, laboratory records for working standards were incomplete, lacking necessary requalification testing.