FDA 483 - L'Oreal USA Products Inc - May 22, 2025
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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.
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ID · 2d74767d-aca9-461f-8549-f4a07968f0f0