Midwest Sterilization Corporation – FDA 483, Jan 12, 2023

Midwest Sterilization Corporation, a contract sterilizer of medical devices in Laredo, TX, received a Form FDA 483 for significant quality system deficiencies. The inspection revealed inadequate procedures for corrective and preventive actions, including the handling of biological indicator failures and changes to sterilization processes. Additionally, the firm failed to adequately establish procedures for routine equipment calibration, specifically concerning concentration and temperature sensors in its sterilization chambers.