FDA 483 - ABC Pharmaceuticals - July 15, 2022

Revance Therapeutics, Inc. in Newark, CA, a drug substance and drug product manufacturer, was cited for three observations during an FDA inspection. The observations included failures in deviation reporting for an equipment leak, inadequate standard operating procedures leading to bioburden contamination, and incomplete documentation regarding cell bank storage facilities in their eCTD submission. These issues indicate deficiencies in quality system controls and documentation practices.