FDA Warns Steam Sterilizer Maker for Lacking Complaint Procedures

June 22, 2011
Wisconsin Aluminum Foundry, a maker of steam sterilizers, lacks several necessary procedures, including procedures for complaint handling and evaluation, an FDA warning letter says. A March 3 inspection found the Manitowoc, Wis., company had a draft procedure for reviewing and evaluating complaints, but it was not fully implemented.
The GMP Letter