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

Sekisui Medical Co., Ltd. underwent an FDA inspection at its API manufacturing facility in Hachimantai, Iwate, Japan, from November 17-21, 2025. The inspection, conducted by Investigator Victoria Spivak, revealed a significant observation regarding the firm's equipment management practices. The primary issue identified was the company's failure to perform routine inspection, checking, Installation Qualification (IQ), or Performance Qualification (PQ) for major equipment critical to the commercial manufacturing of Active Pharmaceutical Ingredients (APIs) for the U.S. market. Specifically, equipment such as (b)(4) in production building (b)(4), used for manufacturing (b)(4) APIs, lacked these essential validation and performance assurance activities. Despite these deficiencies, the firm released and shipped the affected API products to the U.S. market. This observation indicates a deviation from fundamental Good Manufacturing Practices (GMP) that mandate robust programs for qualifying and maintaining manufacturing equipment to ensure consistent product quality and safety. To address this, Sekisui Medical Co., Ltd. is required to develop and implement comprehensive corrective actions, including retrospective qualification where necessary, and establish a compliant system for routine equipment inspection, checking, and qualification to prevent recurrence and ensure adherence to regulatory standards for all U.S.-bound API products.