FDA 483 - Midwest Sterilization Corporation - March 21, 2024

Midwest Sterilization Corporation in Laredo, TX, a contract sterilizer, was inspected by the FDA from March 11-21, 2024. The inspection revealed significant deficiencies across four observations, primarily concerning inadequate equipment calibration and maintenance, lack of procedures for incoming product acceptance, insufficient purchasing data for services, and poorly documented corrective and preventive actions. These issues indicate a systemic breakdown in quality control and documentation practices.