Kaneka Corporation – FDA 483, Feb 6, 2025

An FDA inspection of Kaneka Corporation, a foreign medical device manufacturer in Settsu, Osaka, Japan, revealed two significant observations. The firm failed to adequately identify MDR reportable complaints and conduct thorough investigations into serious adverse events, including patient deaths, related to their Liposorber LA-15 system. Additionally, the company lacked established procedures for identifying and implementing valid statistical techniques for process capability and product characteristics.