FDA 483 - Midwest Products and Engineering Inc - August 29, 2025

An FDA inspection of Midwest Products and Engineering, Inc. in Milwaukee, WI, a medical device contract manufacturer, revealed two significant observations. The firm's corrective and preventive action (CAPA) procedures were found to be inadequately established, with several CAPA records lacking sufficient investigations. Additionally, procedures for ensuring purchased products and services conform to requirements were not adequately implemented, as evidenced by suppliers in "conditional" status without required mitigation plans or audits.