Inspection Record

Revance Therapeutics, Inc. — FDA 483 Findings

US FDAInspected 2022-07-15Published 2025-06-20 3 findingsEquipment and facilityDeviation, CAPA, and investigationOther quality system

View the regulator's official source The source document is always the basis for judgement.

Findings

1Equipment and facility

4 Cell bank storage facility info1mation is not listed in (b)C l _ Specifically, storage ofworking cell bank (b) (4) 4 at <6H l is not listed in Table --­ -------------, ,-----------­ 1: Manufactm·ing and Testing Sites for (b)(4) Dmg Substance in eCTD 3.2.S.2.1 Manufacturers.

2Deviation, CAPA, and investigation

Deviations are not always initiated according to SOP_QA_0042 Deviation Reporting and Handling.

3Other quality system

4 SOP_EQ_0419, Operation and Cleaning of (b) Cl does not contain adequate info1mation to ensure consistent process perfo1mance.

About this record

Extracted automatically from the document US FDA published on 2025-06-20. 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.

Other records for this company

2021-07-02 · US FDA · 4 findings
Revance Therapeutics, Inc. findings history — including this company's other documents US FDA documents, 2025 Go to Findings search