FDA 483 - Grafton Medical Alliance - October 26, 2023

An FDA inspection of Grafton Medical Alliance in Burr Ridge, IL, a repackager/relabeler and specification developer of Class 2 medical devices, identified two significant quality system deficiencies. The firm failed to adequately maintain complaint files, a repeat observation, and did not establish adequate procedures for corrective and preventive actions, including failing to initiate CAPAs for prior FDA audit nonconformances.