Revance Therapeutics, Inc.
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The U.S. Food and Drug Administration (FDA) posted Form 483 to its website on October 12, 2021, which cited issues found during a July 2021 Revance facility inspection. It was noted by The FDA that a working cell bank as a cause of rejected GMP lots of a product, discrepancies between the manufacturing process compared to that proposed for licensure, and said the Company’s quality unit “lacks the responsibility and authority for the control, review, and approval of outsourced activities…”. On October 12, 2021, Revance share prices dropped $6.85, or over 25%, on this news, to close at $20.45.