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.
