FDA 483 - Midwest Sterilization Corporation - February 16, 2024

Midwest Sterilization Corporation, a contract ethylene oxide sterilizer in Jackson, MO, received a Form FDA-483 with six observations. The inspection revealed significant and recurring deficiencies across multiple quality system areas, including inadequate corrective and preventive actions, unvalidated sterilization processes, faulty equipment calibration, and poor environmental controls. These issues, many of which are repeat observations from prior inspections, indicate a systemic failure to maintain a state of control over critical operations.