FDA 483 - Katayama Seiyakusyo Co. Ltd.

An FDA inspection of KATAYAMA SEIYAKUSYO CO., LTD. in Hirakata, Osaka, Japan, an intermediate API and API manufacturer, revealed significant deficiencies across its quality systems, equipment, facilities, production, and laboratory controls. Observations included inadequate water monitoring, incomplete investigation reports, lack of cleaning validation, unverified balances, unsanitary storage conditions, unclear batch record instructions, and compromised sample integrity. These findings indicate a failure to ensure the quality and purity of manufactured products.