FDA Cites Meditherm Facility Over Missing Records, Procedures

The FDA flagged problems with design history files, CAPA procedures and complaint handling at Meditherm during  a May inspection of the device manufacturer’s Tualatin, Oregon facility.

The agency investigators noted in a Form 483 report that the firm had not established design control procedures and it had no design history file documenting design activities for one device, the Med2000 IRIS 7.5.

The facility also lacked written procedures for complaints, CAPAs or medical device reporting. For four repair records addressing complaints about its Med2000 devices, the company failed to document any reason for not investigating the complaints.