Full Range Rehab Cited for Repeat Observations

The FDA hit Full Range Rehab with a Form 483 over repeat observations at its facility in Cincinatti, Ohio.

The company, which manufactures an in-home mechanical overpressure therapy device for restoring knee motion, was cited for multiple repeat observations, including the lack of a procedure for quality system audits.

The firm was also scolded for issues with complaint handling, including a failure to report the only documented complaint it received since the agency’s previous inspection in March 2017.