# FDA 483 - Meddev Corp - March 12, 2025

Source: https://www.globalkeysolutions.net/records/483/meddev-corp/d8a2f3a8-2ea3-49f8-884c-ebc4844488d8

> FDA 483 for Meddev Corp on March 12, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Meddev Corp
- Inspection Date: 2025-03-12
- Product Type: device
- Office Name: San Francisco District Office
- Summary: An FDA inspection of Meddev Corp in Sunnyvale, CA, revealed two significant observations. The firm failed to report a correction or removal of mislabeled medical devices that were surgically implanted, despite acknowledging a risk to health. Additionally, Meddev Corp did not adequately establish records for acceptable suppliers and contractors, lacking critical audit documentation.

## Related Documents

- [483 - 2022-02-28](https://www.globalkeysolutions.net/records/483/meddev-corp/d930f92f-c632-4705-9540-7bc35461528c)

## Related Officers

- [Christopher W. Buser](https://www.globalkeysolutions.net/people/christopher-w-buser/6a11d2e7-dcfa-4542-ba81-b4c6b244ef04)

Company: https://www.globalkeysolutions.net/companies/meddev-corp/f0dc12f6-71b1-431d-b69a-72403f16e212

Office: https://www.globalkeysolutions.net/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df