FDA 483 - Midwest Sterilization Corporation - September 02, 2021

Midwest Sterilization Corp in Jackson, MO, a contract sterilizer, was cited for significant deficiencies in its sterilization process validation, in-process product control, corrective and preventive actions, and equipment calibration. The inspection revealed issues with temperature data retention, inadequate investigations into deviations, and a repeat observation regarding CAPA implementation, indicating systemic quality system failures.