FDA 483 - L'Oreal USA Products Inc - December 04, 2012

L'Oreal USA Products Inc, an OTC drug product manufacturer in Somerset, NJ, was inspected by the FDA and cited for a significant quality control issue. The firm failed to thoroughly review unexplained discrepancies, specifically concerning multiple preservative system failures in various OTC SPF products. This included not consistently identifying specific root causes or implementing systemic corrective actions for these recurring problems.