Carson City, Nevada dental device manufacturer Wykle drew a Form 483 from the FDA for complaint handling deficiencies.
FDA investigators found that the facility failed to complete every complaint record. In one instance, a complaint alleging that the firm’s Class 2 amalgam alloy mixed dry was deemed not to be a complaint after an analysis of the returned product. But the company failed to fill out the investigation section of the record.
In addition, the complaint was still open at the time of the inspection despite the record’s closure section being filled out, the agency said.