FDA 483 - Full Range Rehab LLC - July 28, 2023

During an inspection, Full Range Rehab LLC, a medical device manufacturer in West Chester, OH, was cited for multiple deficiencies in its quality system. Observations included inadequate procedures for corrective and preventive actions, lack of software validation, and insufficient controls for product identification, equipment calibration, incoming product acceptance, and contractor evaluation. These issues indicate a systemic failure to establish and follow essential quality management processes.