FDA 483 - Xinxiang Tuoxin Pharmaceutical Co. Ltd - October 18, 2021

Xinxiang Tuoxin Pharmaceutical Co., Ltd., a drug intermediates manufacturer in Xinxiang, China, was cited for significant quality control deficiencies during an FDA inspection. Observations included poorly maintained manufacturing equipment with potential for product contamination, unvalidated laboratory analytical methods, and inadequate investigation of deviations. Furthermore, the firm lacked proper electronic controls for data integrity in computerized systems.