# FDA 483 - Best Vascular, Inc - July 11, 2025

Source: https://www.keypedia.com/records/483/best-vascular-inc/119bbe39-1813-4c6d-b534-e6bb3319dc5b

> FDA 483 for Best Vascular, Inc on July 11, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Best Vascular, Inc
- Inspection Date: 2025-07-11
- Product Type: device
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Best Vascular, Inc. in Norcross, GA, from July 5-11, 2025, revealed a significant quality system deficiency. The firm failed to adequately document corrective and preventive action (CAPA) activities and effectiveness checks, as required by its own procedures. This indicates a breakdown in the company's quality management processes for its Class III medical device manufacturing.

## Related Officers

- [investigator](https://www.keypedia.com/people/nikki-s-bryant/fe859d4f-23a6-4bc9-94c6-5b3c3fe8d99a)

Company: https://www.keypedia.com/companies/best-vascular-inc/c2e35508-9d72-430b-a51e-13dfcad99b5e

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7
