FDA EIR - Revance Therapeutics, Inc. - July 02, 2021

An FDA Pre-License Inspection of Revance Therapeutics Inc., located in Newark, CA, was conducted from June 21 to July 2, 2021. This comprehensive inspection, performed under the Pre-Approval Inspections regulatory framework (CP 7346.832), evaluated the firm's commercial readiness, conformance to application details, and data integrity for the manufacture of both drug substance and drug product.The inspection revealed several critical issues, documented in a 5-item FDA-483 report. Main violations included a significant lack of commercial production readiness, primarily stemming from rejected drug substance lots attributed to problems with the Working Cell Bank (WCB). A corrective action plan (CAPA 21-017) initiated to address WCB manufacturing and qualification was incomplete. Further observations cited inadequate Quality Unit oversight of a leased testing facility crucial for critical release and stability tests, a lack of appropriate yield calculations during drug product manufacturing, and insufficient control over laboratory analytical worksheets and media fill vials.Although some immediate corrective actions were discussed, the firm disputed one observation regarding its drug substance process. The FDA clarified that the process lacked approval and deviated from the submitted application. The inspection concluded with an initial recommendation to withhold approval due to the firm's lack of readiness for commercial manufacturing. Revance Therapeutics Inc. indicated its intent to formally respond to the observations.