FDA 483 - Revance Therapeutics, Inc. - February 27, 2025

During an inspection conducted by the FDA from February 19 to February 27, 2025, Revance Therapeutics Inc, a manufacturer located in Newark, CA, received a Form FDA 483 document detailing observed deficiencies. The primary issue identified concerned inadequate laboratory controls for bacterial endotoxin testing. Specifically, the firm's standard operating procedure (SOP) for bacterial endotoxin tests for water, cleaned equipment, and components lacked crucial instructions on how to properly mix samples before testing. An investigator observed an endotoxin test where samples were not mixed as part of the analysis procedure. Furthermore, the practice of collecting and storing samples for endotoxin testing in a specific container was also noted. These observations suggest that the established test procedures may not be scientifically sound or appropriately followed to consistently assure product quality and purity. These findings highlight concerns regarding compliance with Good Manufacturing Practices (GMP) under the Federal Food, Drug, and Cosmetic Act. Revance Therapeutics Inc is required to promptly address these observations by developing and implementing robust corrective actions. This includes revising and enhancing their laboratory control procedures, particularly for sample preparation and testing methods for bacterial endotoxins, to ensure that all test results accurately reflect product standards of identity, strength, quality, and purity.