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Medical Devices / Inspections and Audits

Full Range Rehab Cited for Repeat Observations

March 27, 2019
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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.

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