FDA 483 - ABC Pharmaceuticals - July 02, 2021

This FDA Form 483 was issued to Revance Therapeutics, Inc., a drug substance and drug product manufacturer located at 7555 Gateway Blvd., Newark, CA 94560-1152 (FEI: 3007772056). The inspection was conducted from June 21-25, 28-30, and July 1-2, 2021.

Observations noted include: 1. Current release and stability cell bank testing methods (PROT_QC_2711 v1) are insufficient to monitor the quality and shelf-life of working cell banks (WCB). A WCB established in 2012 with a 10-year expiry showed issues, leading to Quality Investigation QI-20-003 identifying WCB effectiveness as the likely root cause. A new WCB is not yet fully qualified. 2. The current drug substance manufacturing process differs from the process proposed for licensure. 3. The firm's Quality Unit lacks responsibility and authority for the control, review, and approval of outsourced activities, specifically not approving the current space and services agreement or implementing a quality agreement. 4. Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate phase of drug product manufacturing. There is no basis for calculating these yields during filling, stoppering, or capping due to