FDA 483 - Parfums Christian Dior - June 13, 2014

An FDA inspection of Parfums Christian Dior in St Jean DE Braye, France, revealed significant deficiencies in quality control and record-keeping for drug products. The firm failed to thoroughly investigate out-of-specification results and deviations, did not report serious adverse events for non-prescription drugs, and maintained inadequate batch production and control records. These issues indicate a lack of robust quality systems, posing potential risks to product quality and patient safety.