FDA 483 - Chongqing Kangle Pharmaceutical Co., Ltd - July 23, 2018

An FDA inspection of Chongqing Kangle Pharmaceutical Co., Ltd in Chongqing, China, a drug manufacturer, revealed a significant issue regarding environmental controls. The firm failed to provide adequate temperature and humidity control in the Solid Raw Material Sampling Room, which is critical for maintaining drug substance product quality. This indicates a potential risk to product integrity due to uncontrolled environmental conditions during raw material sampling.