FDA 483 - Chongqing Southwest No 2 Pharmaceutical Factory Co., Ltd - May 27, 2024

Chongqing Southwest No. 2 Pharmaceutical Factory Co. Ltd, an API manufacturer in Chongqing, China, was inspected by the FDA and received a Form 483 with four observations. The inspection revealed significant deficiencies in reprocessing validation, investigation of out-of-specification results, water system monitoring for microbial contamination, and in-process control procedures. These issues indicate a lack of robust quality control and assurance for products distributed to the US market.