FDA 483 - Parfums Christian Dior - June 08, 2018

An FDA inspection of Parfums Christian Dior in St Jean de Braye, France, revealed significant deficiencies in their manufacturing of over-the-counter (OTC) drug products. The firm lacked adequate written procedures, process and equipment validation, and proper quality control oversight. Issues also included data integrity concerns, insufficient cleaning validation, and inadequate controls over components and rejected materials, indicating a broad failure to adhere to Good Manufacturing Practices.