# FDA 483 - Rebuilder Medical, Inc. - November 29, 2022

Source: https://www.globalkeysolutions.net/records/483/rebuilder-medical-inc/38ec4553-49b7-4791-b76e-64da19754032

> FDA 483 for Rebuilder Medical, Inc. on November 29, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rebuilder Medical, Inc.
- Inspection Date: 2022-11-29
- Product Type: device
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Rebuilder Medical, Inc. in Charles Town, WV, a manufacturer of medical devices, revealed significant deficiencies in its quality system. The firm failed to adequately investigate device complaints, validate embedded software for its ReBuilder models, and document corrective and preventive actions. Additionally, the inspection found issues with risk analysis for device accessories, incomplete device master records, and an inadequate organizational structure lacking quality and regulatory oversight.

## Related Officers

- [Nadia R. Barreda](https://www.globalkeysolutions.net/people/nadia-r-barreda/ef624359-957a-45e4-89c9-5b5ff215c6aa)
- [issuing_officer](https://www.globalkeysolutions.net/people/dennis-r-hock/f13e2db1-b808-466d-a974-e5af2d5dfdb0)

Company: https://www.globalkeysolutions.net/companies/rebuilder-medical-inc/621ad5de-d430-4231-85d4-8029a5351e7b

Office: https://www.globalkeysolutions.net/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8