FDA 483 - AGC WAKASA CHEMICALS CO., LTD. - November 02, 2023

An FDA inspection of AGC Wakasa Chemicals Co., Ltd. in Obama, Fukui, Japan, an API and intermediate manufacturer, revealed significant deficiencies across its quality, production, and laboratory systems. The firm failed to adequately investigate out-of-specification results, ensure proper training for visual inspection personnel, and maintain adequate control over batch records. Additionally, the Quality Unit did not approve scientifically justified and validated analytical procedures for microbial testing of water used in manufacturing.