FDA 483 - FUJIFILM Healthcare Americas Corporation - April 09, 2015

The FDA Form 483 details multiple violations concerning complaint handling, investigations, corrective actions, and reporting for duodenoscopes.

**Complaint Handling Deficiencies:** * Complaints involving device/labeling failure were not consistently reviewed, evaluated, and investigated. * Procedure QA-002, "Reporting Customer Complaints," does not require a complaint record for all alleged deficiencies, specifically excluding device failures due to damage. * Procedures for receiving, reviewing, and evaluating complaints for Medical Device Reporting (MDR) were inadequate, with a lack of MDR reportability review for work orders related to malfunctioned duodenoscopes.

**Investigation Lapses:** * Lack of investigations into failed, returned, and repaired duodenoscopes, including specific instances of fluid damage, light guide assembly damage, and leaks (e.g., ED-530XT Serial No. 4D102A084, 5D102A510; ED-450XTS Serial No. 1D080A030). * Absence of root-cause investigations for recurring issues such as Distal End Cap failures, image failures with water leaks, and peeled surface components on ED-530XT duodenoscopes.

**Corrective and Preventive Actions (CAPA) Inadequacies:** * Procedure QA-006, "Corrective Actions / Preventive Actions (