FDA 483 - Full Range Rehab LLC - January 31, 2019

An FDA inspection of Full Range Rehab LLC, a medical device manufacturer in Cincinnati, OH, revealed significant deficiencies in its quality system. The firm failed to adequately establish procedures for critical processes such as MDR reporting, CAPA, quality audits, complaint handling, device history records, and device master records. Many of these issues were repeat observations from a previous inspection, indicating a persistent lack of compliance.