1Other quality system
Actual yield and percentages of theoretical yield, indicators of rocess erfonnance, are not determined at the conclusion of each appropriate phase of manufacturing fo rug product.
Inspection Record
Revance Therapeutics, Inc. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not always in writing.
3Quality unit oversight
The firm's Quality Unit Jacks 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.
4Other quality system
The current manufacturing process is not the process prnposed for licensure.
About this record
Extracted automatically from the document US FDA published on 2021-10-12. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
