The FDA cited Gendron for shoddy complaint handling and deficient MDR procedures, as well as issues with its internal quality auditing.

The agency’s March inspection of Gendron’s facility in Bryan, Ohio revealed that the company did not notify its regulatory designee, complaint handling unit or company president within a set amount of hours of receiving a potential reportable or MDR complaint. Specifically, no documentation existed to show they were notified of the complaints.

The company also failed to review and investigate MDR reportable complaints and incorrectly assigned risk index levels to complaints, which are assigned by the firm’s complaint handling unit.