Failure to report a voluntary recall to the FDA landed Respire Medical a Form 483 following an April 24 to May 2 inspection at its Brooklyn, New York facility.
The firm issued a recall for its Respire Pink oral sleep apnea device on Sept. 6, 2017, because of a risk of the device’s arm breaking off while in use. Respire issued a recall letter to customers regarding the device failure, but did not report the recall to the FDA.
The FDA said the firm did not adequately investigate complaints involving the possible failure of the device. The investigator said the firm documented the failure but “did not properly investigate to determine why the device broke while in use.”