# FDA 483 - Fermatex Vascular Technologies - June 24, 2025

Source: https://www.keypedia.com/records/483/fermatex-vascular-technologies/7c209278-0862-4ba8-9d53-eaacb655fed3

> FDA 483 for Fermatex Vascular Technologies on June 24, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fermatex Vascular Technologies
- Inspection Date: 2025-06-24
- Product Type: device
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Fermatex Vascular Technologies in Wall Township, NJ, revealed significant deficiencies in manufacturing controls, environmental monitoring, and corrective and preventive action procedures. The firm failed to record critical manufacturing equipment settings in device history records and lacked adequate environmental monitoring for its cleanroom. Additionally, procedures for analyzing quality data for non-conforming products were not established.

## Related Officers

- [Frank J. Marciniak](https://www.keypedia.com/people/frank-j-marciniak/6995351a-6afc-4056-9692-d4aeb711dd92)

Company: https://www.keypedia.com/companies/fermatex-vascular-technologies/42ee7a5f-736d-45ae-a63a-fadb8ecd7a61

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248