Cincinnati, Ohio-based Full Range Rehab failed to file Medical Device Reports within 30 days of receiving information that one of its devices may have caused or contributed to a serious injury, according to a 483 issued to the firm following a Jan. 30-31 inspection.
The FDA said the firm failed to document any corrections for the previous eight observations covering its CAPA system. Moreover, five of the eight observations were repeat observations of repeat observations, including failure to establish an internal audit procedure or to conduct internal audits.
The agency said the firm’s complaint handling procedure did not define all customer complaints. Additionally, the agency found the firm did not record any repairs or complaints. The facility’s quality and compliance manager told inspectors the firm does not routinely record or document device repairs.
Other repeat observations included inadequate device history records and failure to maintain a device master record.
Read the Form 483 here: www.fdanews.com/03-28-19-fullrangerehabllc483.pdf.