FDA 483 - Midwest Sterilization Corporation - November 07, 2018

Midwest Sterilization Corp, a contract sterilizer in Jackson, MO, received a Form 483 with three observations. The inspection revealed significant deficiencies in their corrective and preventive action (CAPA) procedures, including issues with supplier approval and effectiveness monitoring. Additionally, the firm lacked adequate procedures for the disposition of nonconforming product and for ensuring purchased products and services conform to specified requirements.