Kansas Devicemaker Hit for Device History Records
The FDA hit Leawood, Kansas device manufacturer Breathe E-Z Systems with a Form 483 over violations at its facility, including missing device history records and the lack of a standard operating procedure for handling complaints.
During its July 15-17 inspection, the agency found that the firm had been manufacturing a class II device, the CO Sleuth carbon monoxide analyzer, since November 2012, but had no device history records.
The facility also lacked procedures for acceptance activities. Procedures to control the acceptance of incoming materials, in-process devices, and finished devices were not established, the agency said. The company also lacked an SOP for complaints.