# FDA 483 - VistaMed Ltd t/a Freudenberg Medical - April 03, 2025

Source: https://www.keypedia.com/records/483/vistamed-ltd-ta-freudenberg-medical/0d2b32a8-82b7-4491-bbcd-35ea0cf853f2

> FDA 483 for VistaMed Ltd t/a Freudenberg Medical on April 03, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: VistaMed Ltd t/a Freudenberg Medical
- Inspection Date: 2025-04-03
- Product Type: device
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of VistaMed Ltd t/a Freudenberg Medical in Carrick-on-Shannon, Ireland, revealed significant deficiencies in their contract manufacturing operations for the BioMimics 3D Vascular Stent System. Observations included inadequate process control procedures, insufficient procedures for incoming product acceptance, and a failure to properly identify the acceptance status of products, specifically regarding sterile labeling for non-sterilized devices. These issues indicate a lack of robust quality system controls.

## Related Documents

- [483 - 2016-11-16](https://www.keypedia.com/records/483/vistamed-ltd-ta-freudenberg-medical/4878760d-3cd7-41fd-b5e7-6ec039f88bed)

## Related Officers

- [Felix J. Marrero](https://www.keypedia.com/people/felix-j-marrero/fe3bf64e-987b-40d9-8a17-754d58e13433)

Company: https://www.keypedia.com/companies/vistamed-ltd-ta-freudenberg-medical/2d48b9ab-86ca-4179-a021-cf7a8d5359c5

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