# FDA 483 - Rapid Reboot Recovery Products, LLC - September 08, 2022

Source: https://www.keypedia.com/records/483/rapid-reboot-recovery-products-llc/3809246c-c7e5-492f-babe-a439edc8bb5b

> FDA 483 for Rapid Reboot Recovery Products, LLC on September 08, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rapid Reboot Recovery Products, LLC
- Inspection Date: 2022-09-08
- Product Type: device
- Office Name: Denver District Office
- Summary: An FDA inspection of Rapid Reboot Recovery Products, LLC in Lindon, UT, a manufacturer of Regen devices, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for design changes, control nonconforming products, and maintain device history records. Additionally, issues were noted with supplier quality agreements, complaint file maintenance, and corrective and preventive action documentation.

## Related Officers

- [Rebecca L. Stephany](https://www.keypedia.com/people/rebecca-l-stephany/33f38e32-c0a6-4292-a515-ab3f6ca6503a)

Company: https://www.keypedia.com/companies/rapid-reboot-recovery-products-llc/ce2aadd0-2ebf-455d-910d-2b548c130762

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