Audifon-USA established inadequate procedures for complaint reviews, corrective and preventive actions, equipment calibration, and other activities, according to a Form 483.
During a July inspection of the company’s Debary, Fla., facility, the FDA found several defects in Audifon’s complaint handling procedures.
Specifically, there was no requirement that all complaints be evaluated to determine if they involved reportable events; the procedure and work instructions did not define “complaint” to help identify complaints; there were no provisions to ensure that returned devices handled as repairs were evaluated to see if they should be classified as complaints; and there were no provisions to describe requirements for a complaint investigation, including identification of the most likely underlying cause.
Investigators also observed that Audifon’s corrective and preventive action procedures were not verified or validated prior to implementation.
In addition, the company was observed not to have maintained procedures for calibrating and maintaining some of its hearing aid components.
Investigators also reported that Audifon had not established procedures that described how non-conforming products were documented, including use of the firm’s rejection tickets. These procedures also did not include provisions for rework.
Finally, the company’s written MDR procedures did not include provisions to identify and report serious injuries and malfunctions, and they did not address eMDR reporting requirements.