Ohio Device Manufacturer Scolded for MDR Procedure, Complaint Handling

The FDA slapped Gendron with a Form 483 for shoddy complaint handling and deficient MDR procedures, as well as issues with its internal quality auditing.

The inspection, which was conducted in March, 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 that 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.

Documentation also did not exist showing that the firm’s complaint handling unit evaluated complaint logs for any potential reportable complaints and noted trends that warranted further review. The lack of documentation made the investigator unable to verify that complaint log reviews were being conducted.

In addition, the firm’s internal quality audit procedure lacked requirements for necessary audits. For example, the firm did not audit all areas of its quality management system, such as medical device reporting and control of nonconforming material.

Gendron’s purchasing control procedure also did not adequately define controls for suppliers. The procedure required suppliers to complete a vendor report card to determine if an on-site audit is required but did not specify the frequency of the assessment.