FDA WARNING_LETTER - FUJIFILM Healthcare Americas Corporation - May 01, 2015

The FDA issued a Warning Letter to Fujifilm Corporation following inspections in April-May 2015 at four facilities (Miyanodai, Mito, Sano, and Wayne) that manufacture endoscopes and accessories. The inspections revealed that Fujifilm's devices are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Design Control (21 CFR 820.30):** Failure to establish and maintain design control procedures, exemplified by inadequate reprocessing validation for the ED-530XT duodenoscope and insufficient verification of an air leak tester. 2. **Corrective and Preventive Action (CAPA) (21 CFR 820.100(a)):** Failure to establish and maintain CAPA procedures, including not analyzing quality data from complaints for recurrent failures, lacking criteria for determining necessary and effective corrective actions, and inadequate review of service/repair data for complaint determination. 3. **Incoming Product Acceptance (21 CFR 820.80(b)):** Failure to establish and maintain procedures for incoming product acceptance, such as not requiring inspection of critical components, lacking written acceptance criteria for subassemblies, and not inspecting for shipping damage or verifying properties of critical materials. 4. **Process Validation (21 CFR