Company

United StatesPublic company, NASDAQ: AQST

Aquestive Therapeutics (NASDAQ: AQST), Portage, IN – FDA Inspections

Inspection records and compliance data for Aquestive Therapeutics in Portage, Indiana. 6 FDA inspections on record, 1 Form 483, last inspected January 30, 2025. Publicly traded as NASDAQ: AQST.

Company Profile

This profile covers Aquestive Therapeutics based in Portage, Indiana, United States.

FDA Inspection History

FDA inspections: 6
OAI: 0
VAI: 5
NAI: 0
Unclassified: 1
Form 483s: 1
Warning letters: 0

First inspected October 23, 2008. Last inspected January 30, 2025.

Most cited issue areas

Procedures not in writing, fully followed4 inspections
Complaint Handling Procedure1 inspection
Investigations of discrepancies, failures1 inspection

FDA inspections (6)

Date	Result	FDA center(s)	Insp. #
January 30, 2025	Not classified	Human Drugs	1256378
April 3, 2015	VAI	Human Drugs · Drug Quality Assurance	921152
September 13, 2012	VAI	Human Drugs · Drug Quality Assurance	800838
June 28, 2011	VAI	Human Drugs · Drug Quality Assurance	731926
March 23, 2010	VAI	Human Drugs · Drug Quality Assurance	653083
October 23, 2008	VAI	Human Drugs · Drug Quality Assurance	544288

FDA documents

Form 483s (1)

Form 483s · January 30, 2025

People (1)

Muna Algharibeh

Person

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