FDA 483 - Sanmina Sci Israel Medical Systems Ltd. - June 16, 2022

An FDA inspection of Sammina Sci Israel Medical Systems Ltd. in Maalot, Israel, a contract manufacturer, from June 13-16, 2022, identified a significant issue with the firm's process validation documentation. The company failed to adequately document performance qualification activities and manufacturing line validations for the assembly of the QDOT MICRO System Mother Board. This indicates a deficiency in their quality system regarding process control and record-keeping.