FDA 483 - Organon Pharma (UK) Ltd. - June 13, 2025

An FDA inspection of Organon Pharma (UK) Ltd. in Cramlington, United Kingdom, a drug manufacturer, revealed three significant observations. Deficiencies included inadequate testing of components used in drug product manufacturing, failure to follow quality control unit procedures for labeling rejected materials, and insufficient cleaning validation studies for non-dedicated equipment, potentially leading to contamination.