FDA 483 - Changzhou Tianhua Pharmaceutical Co., Ltd. - April 19, 2019

An FDA inspection of Changzhou Tianhua Pharmaceutical Co., Ltd. in Jintan, Jiangsu, China, a manufacturer of intermediates and APIs, revealed significant deficiencies. Observations included inadequate personnel training, incomplete batch production records, and failures in equipment calibration and maintenance. The firm also lacked complete investigations for Out-Of-Specification results and proper written procedures for equipment cleaning.