FDA 483 - Sekisui Medical Co., Ltd. - November 21, 2025

Sekisui Medical Co., Ltd. in Hachimantai, Japan, an API manufacturer, was cited for failing to perform routine inspection and checking of automatic, mechanical, and electronic equipment. Specifically, the firm did not conduct Installation Qualification (IQ) or Performance Qualification (PQ) for major equipment used in the commercial manufacturing of APIs for the US market. This deficiency led to the release and shipment of unvalidated products to the US market.