FDAnews Device Daily Bulletin
Medical Devices / Inspections and Audits

Michigan Devicemaker Hit for Complaint Procedures

Sept. 13, 2019

The FDA hit Sturgis, Michigan orthotic devicemaker Freeman Manufacturing with a Form 483 over its complaint handling procedure, which did not establish a process for investigating complaints.

The agency noted a complaint during its March 6-7 inspection involving “material separations from plastic” that contained no details of an investigation.

Another customer complained that a product it received was “too small,” but the customer’s name, address and phone number were not taken down in the complaint, and no investigation details or replies were documented.

View today's stories