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# Revance Therapeutics FDA-483 Released
- URL: https://www.fdaweb.com/revance-therapeutics-fda-483-released/
- Published: 2021-10-13T12:00:00.000Z
- Updated: 2026-09-14T17:18:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150360

FDA has released the FDA-483 with five inspection observations issued following a 6/21-7/2 inspection at Revance Therapeutics, a Newark, CA, drug substance and drug product manufacturer. The inspection observations were: 

- current release and stability cell bank testing methods are insufficient to monitor quality and shelf-life of working cell bank;
- the current manufacturing process is not the process proposed for licensure;
- the firm’s quality unit lacks the responsibility and authority for the control, review, and approval of outsourced activities, which includes defining the responsibilities and communication processes for quality-related activities in a written agreement;
- actual yield and percentages of theoretical yield, indicators of process performance, are not determined after each appropriate phase of manufacturing for a redacted drug product; and
- the responsibilities and procedures applicable to the quality control unit are not always in writing.