FDA EIR - Sekisui Medical Co., Ltd - October 17, 2019

An FDA inspection of Sekisui Medical Co., Ltd, a contract manufacturer of Class II in-vitro diagnostic medical devices in Ryugasaki-Shi, Japan, was conducted from October 15-17, 2019. The inspection, carried out under the Compliance Program C.P. 7382.845 for Medical Device Manufacturers, identified four significant deficiencies, resulting in an FDA-483 issuance to the Plant Manager. The main violations included: (1) failure to adequately validate a critical mixing process for solution homogeneity in their High-density lipoprotein (HDL) cholesterol tests; (2) inadequately established procedures for Corrective and Preventive Actions (CAPA), specifically lacking comprehensive data source analysis and clear triggers for initiating CAPAs, leading to multiple unaddressed non-conforming products (a repeat observation); (3) insufficient procedures for controlling non-conforming products, including inadequate documentation and a failure to evaluate certain non-conforming items before disposal; and (4) an inadequately maintained Device History Record (DHR) for HDL products, specifically not documenting or referencing measuring devices used in component formulation. In response, company management "promised to correct" all observations and committed to submitting a detailed written response to the FDA within 15 business days.