# FDA 483 - Access Vascular, Inc - November 25, 2025

Source: https://www.keypedia.com/records/483/access-vascular-inc/c676e4e3-7139-41e9-9455-5284eda01b49

> FDA 483 for Access Vascular, Inc on November 25, 2025. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Access Vascular, Inc
- Inspection Date: 2025-11-25
- Product Type: devices
- Summary: During an inspection conducted by the FDA from November 19 to November 25, 2025, the firm located in Winchester, MA, received a Form FDA-483. The primary observation noted was that procedures for corrective and preventive action (CAPA) were not adequately established. Specifically, the firm's "Corrective and Preventive Action" procedure, SOP-008 Rev F, permits the implementation of CAPA without verifying their effectiveness and ensuring they do not adversely affect the finished device.

Further details highlighted that Section 6.5.6 of the procedure allows for justification to bypass effectiveness verification. Two out of twelve reviewed CAPA files, specifically CAPA 24-013 concerning usability documentation gaps and CAPA 24-016 regarding supplier management documentation deficiencies, were implemented solely based on document creation and approval. This approach failed to verify whether the actions effectively resolved systemic issues or prevented recurrence.

The FDA-483 is issued under Section 704(b) of the Federal Food, Drug and Cosmetic Act, signifying inspectional observations that do not constitute a final determination of compliance. The firm is responsible for performing internal self-audits to identify and correct all violations of quality system requirements. The CEO, James F. Biggins, was made aware of these observations, and the firm has indicated a promise to correct the issue.

## Related Documents

- [483 - 2025-11-25](https://www.keypedia.com/records/483/access-vascular-inc/c1b39ab1-f18c-4405-8ed8-1029077713f6)

## Related Officers

- [investigator](https://www.keypedia.com/people/james-p-finn/70e5c36c-2711-449b-bf73-e08b4dd58449)

Company: https://www.keypedia.com/companies/access-vascular-inc/1eb11f71-0bf2-463d-81be-9307bf5c33da