FDA 483 - Daiichi Sankyo Chemical Pharma Co., Ltd. - December 22, 2023

An FDA inspection of Daiichi Sankyo Chemical Pharma Co., Ltd. in Iwaki, Fukushima, Japan, revealed significant deficiencies in quality control and production processes. The firm failed to thoroughly investigate unexplained discrepancies, out-of-specification results, and foreign matter, and lacked adequate production controls to prevent residue build-up in equipment during API manufacturing campaigns. These issues indicate a lack of robust quality systems to ensure drug product quality.