North Carolina Devicemaker Rapped for Lacking Procedures

The FDA hit devicemaker Medfaxx for lacking required procedures at its Wake Forest, North Carolina facility, issuing the company a Form 483.

The agency’s inspection revealed that there were no procedures in place for controlling device design to ensure the device meets specifications.

In addition, written procedures for medical device reporting and CAPA handling were not established, and the firm was written up for lacking complaint handling procedures.