FDA 483 - Neuro Rehab VR - October 27, 2023

Neuro Rehab VR, a medical device manufacturer in Fort Worth, TX, was cited for significant quality system deficiencies during an FDA inspection. Observations included inadequate software validation documentation, failure to maintain supplier evaluation records, and critical non-compliance with Unique Device Identification (UDI) requirements for its XR Therapy System. These issues indicate a lack of robust quality control and regulatory adherence for commercially distributed devices.