FDA 483 - Aquestive Therapeutics - January 30, 2025

An FDA inspection of Aquestive Therapeutics in Portage, Indiana, revealed two significant observations. The firm failed to thoroughly investigate product complaints, specifically regarding white spots on SUBOXONE® sublingual film, and lacked adequate corrective and preventive actions. Additionally, the company did not have sufficient systems in place to comply with the Drug Supply Chain Security Act's verification requirements for suspect and illegitimate products.