FDA 483 - Rafa Laboratories Ltd. - November 25, 2019

An FDA inspection of Rafa Laboratories Ltd. in Jerusalem, Israel, a drug product manufacturer, revealed significant deficiencies across multiple areas. Observations included incomplete batch production records, failure to establish time limits for production phases, and inadequate investigations into unexplained discrepancies. Additionally, issues were noted with equipment qualification, environmental monitoring in aseptic processing areas, and adherence to laboratory control mechanisms.