FDA 483 - Rafa Laboratories Ltd. - November 13, 2017

Rafa Laboratories Ltd. in Jerusalem, Israel, a drug manufacturer, was cited with six observations during an FDA inspection from November 5-13, 2017. The inspection revealed significant deficiencies in aseptic processing, quality control unit responsibilities, test method validation, equipment cleaning procedures, deviation handling, and production/process control documentation. These issues indicate a lack of adherence to established procedures and controls necessary to ensure drug product quality and sterility.