483
Rapid Reboot Recovery Products, LLCRapid Reboot Recovery Products, LLC – FDA 483, Sep 8, 2022
Record Details
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.
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ID · 3809246c-c7e5-492f-babe-a439edc8bb5b
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