# FDA 483 - International Medical Development, Inc. - February 12, 2021

Source: https://www.globalkeysolutions.net/records/483/international-medical-development-inc/169453d3-0569-41fb-9444-d8ba33152062

> FDA 483 for International Medical Development, Inc. on February 12, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: International Medical Development, Inc.
- Inspection Date: 2021-02-12
- Product Type: device
- Office Name: Denver District Office
- Summary: An FDA inspection of International Medical Development, Inc. in Huntsville, UT, a specification developer, revealed significant deficiencies across its quality system. The firm failed to adequately establish procedures for design change, supplier control, non-conforming product, corrective and preventive actions, labeling, device master records, device history records, internal audits, and management review. Several observations were repeats from prior FDA inspections and a Warning Letter, indicating persistent quality system issues.

## Related Documents

- [483 - 2026-07-19](https://www.globalkeysolutions.net/records/483/international-medical-development-inc/8344cb11-e294-4de7-a906-2f4ba24edfcb)

## Related Officers

- [James R. Montero](https://www.globalkeysolutions.net/people/james-r-montero/ce2d19fd-25b7-423e-9132-5d6f582380d2)

Company: https://www.globalkeysolutions.net/companies/international-medical-development-inc/49008fea-55b6-44d8-9a0c-f632d2ca6741

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face