FDA 483 - Taurus Engineering and Manufacturing, Inc. - March 10, 2022

An FDA inspection of Taurus Engineering and Manufacturing, Inc. in Saint Paul, MN, conducted from March 7-10, 2022, identified significant deficiencies in the firm's corrective and preventive action (CAPA) procedures. The company failed to adequately establish and verify the effectiveness of CAPAs, resulting in issues such as missing documentation for machine downtime, unverified effectiveness checks, and undocumented employee retraining.