FDA 483 - Estee Lauder N.V. - April 26, 2024

An FDA inspection of Estee Lauder N.V., an OTC drug manufacturer in Oevel, Belgium, from April 22-26, 2024, identified a significant deficiency in their quality control. The firm's quality unit failed to adequately test incoming high-risk drug components for impurities. This lapse raises concerns about the purity and safety of OTC drug products manufactured and distributed to the U.S. market.