FDA Warns Steam Sterilizer Maker for Lacking Complaint Procedures

June 24, 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. Two complaints about the sterilizers had not been reviewed, evaluated and investigated, according to the May 12 letter posted online May 24.
The GMP Letter