# FDA 483 - Agile Devices, Inc. - February 20, 2026

Source: https://www.globalkeysolutions.net/records/483/agile-devices-inc/998e266c-ec0a-4207-851d-24ae1a8992cf

> FDA 483 for Agile Devices, Inc. on February 20, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Agile Devices, Inc.
- Inspection Date: 2026-02-20
- Product Type: device
- Office Name: New England District Office
- Summary: Agile Devices, Inc. in Newton Center, MA, was inspected and received a Form 483 with five observations. The inspection revealed significant deficiencies in design control, complaint handling, corrective and preventive actions (CAPA), supplier management, and risk management processes, particularly concerning the Angler Microcatheter. These issues indicate a lack of adequate procedures and adherence to existing ones, potentially impacting device safety and performance.

## Related Documents

- [483 - 2023-09-15](https://www.globalkeysolutions.net/records/483/agile-devices-inc/ce493350-0bc8-4121-a593-c532741e47f7)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/agile-devices-inc/a9abef1a-2d26-4e2c-8c33-ff3e31b5302e

Office: https://www.globalkeysolutions.net/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144