FDA EIR - Fujifilm Medical Systems USA, Inc. - November 08, 2017

This FDA inspection of Fujifilm Medical Systems USA, Inc.'s Morrisville, NC facility, conducted on November 7-8, 2017, was a routine, initial inspection of a Class II medical device manufacturer. The inspection, performed under Compliance Program 7382.845, focused on Management Controls, Corrective and Preventive Action (CAPA), and Design Controls for the company's radiological software programs, Synapse PACS and Synapse CV. The firm acts as a specification developer for these Picture Archiving and Communication Systems.

While no FDA-483 Inspectional Observations were issued, the inspector discussed three key areas for improvement. Firstly, the company's headquarters, responsible for Medical Device Reporting, failed to report a second instance of a known software malfunction in Synapse PACS (complaint 6999), despite it having the same failure mode, root cause, and health risk as a previously reported event (complaint 6881), which is contrary to reporting requirements under 21 CFR §803. Each reportable event must be documented.

Secondly, a deficiency in the firm's training program was noted; an employee conducted design validation testing for Synapse PACS version 5.4, yet their training records for "software testing" were incomplete, violating the company's own procedures for essential job functions. Lastly, the CAPA form included an option to skip verification/validation of corrective actions, potentially undermining quality processes. Management committed to revising this form. These discussions highlight areas for enhanced procedural adherence and reporting accuracy.