ABC Pharmaceuticals – FDA EIR, Jul 15, 2022

An FDA follow-up inspection of Revance Therapeutics, Inc.'s drug substance and drug product manufacturing facilities in Newark, California, took place from July 11-15, 2022. The inspection's primary purpose was to support the resubmission of Biologics License Application (BLA) 761127 for DaxibotulinumtoxinA for Injection. Conducted under established Good Manufacturing Practices (GMP) and specific FDA compliance policies, the review thoroughly assessed the company’s Quality, Facilities/Equipment, Production, Materials, and Laboratory Control systems.

Previous observations from a 2021 inspection were successfully verified as corrected. However, the latest review identified three new issues, formally issued on an FDA Form 483. These observations highlighted: 1) instances where deviations were not consistently initiated according to standard operating procedures; 2) an equipment operation and cleaning procedure lacking sufficient detail for consistent process performance; and 3) the absence of specific cell bank storage facility information within the submitted BLA. Revance Therapeutics' management acknowledged these findings and committed to providing a comprehensive response within 15 business days, outlining their corrective actions.