Neuromonics Hit for Problems with Complaint Handling, Reporting

The FDA has cited Neuromonics in a Form 483 for quality system failures, including lax complaint handling and failure to maintain and implement written device reporting procedures.

The agency found that the company’s Westminster, Colo., facility failed to document medical device reporting evaluations for 16 customer complaints regarding its Oasis kit, a device for treating tinnitus.

The FDA investigator also found that there was no documentation of incoming acceptance activities for certain products used in the kit.