FDA 483 - Midwest Sterilization Corporation - March 22, 2018

An FDA inspection of Midwest Sterilization Corp. in Jackson, MO, a contract sterilizer, revealed significant deficiencies in their quality system. Observations included inadequate procedures for corrective and preventive actions, unvalidated changes to production software, and insufficient validation of equipment calibration procedures. These issues indicate a lack of robust control over critical sterilization processes.