Failure to validate and document significant manufacturing processes and quality assurance tests to assure specific requirements are met, e.g., robot and manual welding processes, and software used to program the chip in the control device of the automatic air mattress.
Your firm’s response dated July 30, 1998 and signed by Edward A. Kroll, Director, TQM and Regulatory Affairs, to FDA 483, Item #1 is inadequate because no documentation of the software validation was provided or available to the investigator for his review, nor is it provided in the response. We do not believe there was any miscommunication, since the investigator requested to see the software documentation used to program the chip for controlling the device and none was available according to your firm’s Quality Manager (QM). Your firm’s response also addresses the validation that will be conducted covering the welding processes. Please provide copies of the completed validation runs for our review and file. Pending our review of this documentation we will verify this corrective action during the next inspection of your firm.