FDA 483 - Somavac Medical Solutions, Inc. - June 24, 2021

An FDA inspection of Somavac Medical Solutions, Inc. in Memphis, TN, identified significant deficiencies in their quality system. The firm failed to adequately establish procedures for corrective and preventive actions, lacking investigation plans and proper documentation. Additionally, issues were noted with design validation procedures, specifically regarding the inclusion and execution of intended use validation for their SOMAVAC device.