FDA 483 - ITG-Medev, Inc. - June 06, 2018

ITG Medev Inc. in San Francisco, CA, was inspected and received a Form FDA-483 with seven observations. The inspection revealed significant deficiencies in the firm's quality system, including a failure to revalidate a sterilization process after changing sterilizers for their Omiderm wound dressing, inadequate procedures for finished device acceptance, and a complete lack of quality audits and management reviews for at least five years. These issues indicate a severe breakdown in quality management practices for a manufacturer of sterile medical devices.