Wisconsin Aluminum Foundry Co – FDA Warning Letter

On March 3, 2011, an FDA inspection of Wisconsin Aluminum Foundry Co. in Manitowoc, Wisconsin, revealed that the firm's manufactured steam sterilizers, classified as medical devices, were adulterated. The manufacturing, packing, storage, or installation methods and controls did not conform to the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Violations included: 1. Failure to maintain a Device Master Record (21 CFR 820.181), lacking device specifications or production/quality assurance procedures. 2. Failure to maintain Device History Records (21 CFR 820.184), with no records of device assembly or acceptance testing. 3. Failure to establish procedures for finished device acceptance (21 CFR 820.80(d)), including written testing procedures and documentation instructions. 4. Failure to establish procedures for incoming product acceptance (21 CFR 820.80(b)), lacking written incoming inspection procedures and documentation instructions. 5. Failure to establish adequate procedures for receiving, reviewing, and evaluating complaints (21 CFR 820.198(a)), as Procedure No. 7.5.1.7 was in draft form and not implemented. 6. Failure to review and evaluate complaints to determine investigation necessity (2