FDA 483 - Tianjin Asymchem Pharmaceuticals Co., Ltd. - December 06, 2019

Tianjin Asymchem Pharmaceuticals Co., Ltd., an API manufacturer in TEDA West Tianjin, P.R. China, was cited for significant deficiencies in laboratory controls, including analytical method validation, release testing, and data validity. Additional observations noted inadequate procedures for establishing retest dates, failures in Quality Unit responsibilities, insufficient change control, and improper equipment surface construction. These issues indicate a lack of robust quality systems for API manufacturing.