FDA 483 - L'Oreal USA Products Inc - May 22, 2025

An FDA inspection of L'Oreal USA Products Inc. in Piscataway, NJ, from May 15-22, 2025, revealed significant deficiencies in quality control and data integrity. The firm failed to conduct adequate temperature and humidity mapping studies for stability chambers and maintained a deficient change control system with numerous overdue change controls. These issues indicate a lack of adherence to established procedures and proper oversight of critical manufacturing processes.