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# FDA Releases EIR of Troubled Revance Facility
- URL: https://www.fdaweb.com/fda-releases-eir-of-troubled-revance-facility/
- Published: 2021-11-19T12:00:00.000Z
- Updated: 2026-09-14T17:23:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150619

FDA has released the [Establishment Inspection Report](https://www.fda.gov/media/154261/download?ref=fdaweb.com) (EIR) associated with a complete response letter issued to Revance Therapeutics on its BLA for daxibotulinumtoxinA for injection and its use in treating moderate to severe glabellar (frown) lines. The EIR recommended that the agency withhold approval of the BLA due to the manufacturing facility’s lack of commercial readiness. The company had earlier said it plans to request a Type A meeting with FDA as soon as possible to address the deficiencies raised.

Last month, FDA released a [7/2 FDA-483](https://www.fda.gov/media/153014/download?ref=fdaweb.com) with five inspection observations issued following the 6/21-7/2 inspection at the firm’s Newark, CA drug substance and drug product manufacturing facility. 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.

DaxibotulinumtoxinA is the company’s next-generation neuromodulator product that “combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components,” Revance says. DaxibotulinumtoxinA is also being evaluated in the full upper face, including glabellar lines, forehead lines and crow’s feet, as well as in two therapeutic indications — cervical dystonia and adult upper limb spasticity.