FDA 483 - Shanghai Kyowa Amino Acid Co., Ltd. - December 11, 2023

Shanghai Kyowa Amino Acid Co., Ltd. received an FDA Form 483 with one repeat observation during an inspection of its API manufacturing facility in Shanghai, China. The observation cited the firm for failing to follow its written production and process control procedures. Specifically, the firm did not initiate deviation investigations for observed corrosion and rust in manufacturing tanks, despite its own SOP requiring such actions.