FDA 483 - ABC Pharmaceuticals - February 27, 2025

Revance Therapeutics Inc. in Newark, CA, was inspected by the FDA from February 19-27, 2025. The inspection revealed a significant deficiency in laboratory controls, specifically regarding bacterial endotoxin testing procedures. The firm's SOP lacked instructions for sample mixing, and samples were improperly collected and stored, indicating a failure to ensure product quality and purity.