FDA 483 - Fujifilm Corporation - July 13, 2018

An FDA inspection of Fujifilm Corporation, a medical device manufacturer in Ashigarakami-gun, Kanagawa, Japan, revealed significant deficiencies in its complaint handling procedures for the ASPIRE Cristalle with Digital Breast Tomosynthesis (DBT) Option. The firm failed to adequately document complaints, ensure completion of corrective actions, and identify root causes for reported issues. These findings indicate a lack of robust controls in the firm's quality system for managing complaints.