FDA 483 - Chongqing Daxin Pharmaceutical Co., Ltd. - May 11, 2018

An FDA inspection of Chongqing Daxin Pharmaceutical Co., LTD., an API manufacturer in Chongqing, P.R. China, revealed several deficiencies. These included issues with process validation for optimized manufacturing processes, failure to use worst-case parameters in validation studies, and inadequate microbiological identification and environmental monitoring procedures, specifically lacking characterization of normal organisms and established action limits for clean area monitoring.