FDA 483 - I.T.S. GmbH - May 03, 2019

T.B.S. GmbH, a manufacturer of Class 2 medical devices, was cited for three observations during an FDA inspection. The firm failed to submit Medical Device Reports (MDRs) within 30 days for two instances of broken bone fixation plates. Additionally, the company's corrective and preventive action (CAPA) procedures lacked documented verification of effectiveness, and its supplier evaluation procedures were inadequate, failing to include service providers.