FDA 483 - Medstrat, Inc. - March 10, 2022

Medstrat, Inc. in Downers Grove, IL, a medical device manufacturer, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately establish procedures for corrective and preventive actions, including issues with lost CAPA files and a lack of effectiveness checks. Additionally, complaint files were not adequately maintained, specifically lacking records of communication with complainants.