FDA 483 - Aquestive Therapeutics Inc. - October 07, 2021
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An FDA inspection of Aquestive Therapeutics Inc. revealed significant deficiencies in their post-marketing adverse drug experience reporting system. The firm lacked complete written procedures for surveillance, receipt, evaluation, and reporting of adverse drug experiences. Additionally, the company failed to submit several required periodic and annual reports in a timely manner for their approved drug applications, indicating systemic issues with pharmacovigilance compliance.
ID · 8a5c02ec-4264-46b0-a064-c4c2c3bd734a