FDA 483 - Fujifilm Corporation - September 22, 2023

Fujifilm Corporation, a medical device manufacturer in Ashigarakami-Gun, Japan, was cited for three observations during an FDA inspection. The firm failed to adequately establish corrective and preventive action procedures, including missing documentation for design transfers and complaint reviews. Additionally, the company submitted Medical Device Reports (MDRs) with incomplete information, specifically regarding the manufacturing site and patient identifiers.