FDA 483 - FUJIFILM Healthcare Americas Corporation - July 02, 2019

Fujifilm Medical Systems U.S.A., Inc. in Wayne, NJ, was inspected regarding its complaint file establishment. The inspection revealed deficiencies in the firm's complaint handling procedures, specifically regarding the closure of complaint investigations and the documentation of decisions not to report potential Medical Device Reports (MDRs). These issues indicate a lack of adherence to established internal procedures for record-keeping and decision deliberation.