FDA 483 - L'Oreal Usa, Inc. - April 01, 2026

An FDA inspection of L'Oreal Usa, Inc. in Florence, KY, an OTC drug manufacturer, revealed significant deficiencies in material control and quality unit procedures. Observations included inadequate storage and control of drug labels, insufficient segregation of rejected materials, and a lack of written procedures for the quality control unit, including OOS investigations and batch record review. These issues pose risks of product mix-ups and compromised quality.