Aquestive Therapeutics Inc. – FDA EIR, Oct 7, 2021

The FDA conducted a routine Postmarketing Adverse Drug Experience (PADE) inspection of Aquestive Therapeutics Inc. in Warren, NJ, from September 29 to October 7, 2021. This inspection aimed to assess the company's compliance with applicable pharmacovigilance regulations, specifically referencing the Postmarketing Adverse Drug Experience Reporting Inspections Compliance Program Guidance Manual. During the inspection, four significant observations were documented on Form FDA-483.

The main issue identified was the absence of complete written procedures for the surveillance, receipt, evaluation, and reporting of postmarketing adverse drug experiences. This included gaps in procedures for documenting adverse event source information, defining initial awareness dates, handling off-hours events, ensuring reconciliation with pharmacovigilance vendors, conducting literature searches, and detailing processes for case receipt, evaluation, and electronic reporting intervals for periodic safety and annual reports. Furthermore, the company failed to submit one quarterly periodic adverse drug experience report for NDA 022524 Zuplenz and submitted another quarterly report for NDA 210833 Sympazan three days late. Two annual reports for NDA 022524 Zuplenz were also submitted beyond their required due dates. Aquestive Therapeutics' management acknowledged these findings and committed to providing a written response within 15 business days, outlining their corrective actions to address the identified regulatory deficiencies and enhance their pharmacovigilance practices.