483
FUJIFILM MEDWORK GMBHFDA 483 - FUJIFILM MEDWORK GMBH - March 26, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
During an inspection, FUJIFILM MEDWORK GMBH was cited for failing to submit a Medical Device Report (MDR) to the FDA within 30 days. This violation involved a serious adverse event where parts of a biopsy valve were found inside a patient, despite the firm distributing the device in the U.S. and causality being proven. The firm's failure to report indicates a significant lapse in post-market surveillance and regulatory compliance.
Open in Dashboard
ID · f3be4e09-2a42-4e7c-9d53-82b6528986e6