# FDA 483 - FUJIFILM MEDWORK GMBH - March 26, 2025

Source: https://www.keypedia.com/records/483/fujifilm-medwork-gmbh/f3be4e09-2a42-4e7c-9d53-82b6528986e6

> FDA 483 for FUJIFILM MEDWORK GMBH on March 26, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: FUJIFILM MEDWORK GMBH
- Inspection Date: 2025-03-26
- Product Type: device
- Office Name: Office of Inspections and Investigations
- Summary: 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.

## Related Officers

- [Katlin N. Stubbs](https://www.keypedia.com/people/katlin-n-stubbs/27d70db1-a2e9-4254-a721-c6de655f7626)

Company: https://www.keypedia.com/companies/fujifilm-medwork-gmbh/bcc6526e-6ab5-414d-b05b-f93f1940e3ec

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8