FDA Inspection
Aquestive Therapeutics Inc.Aquestive Therapeutics Inc. – FDA Inspection, Oct 7, 2021
Record Details
This FDA Inspection record concerns Aquestive Therapeutics Inc., with an inspection on October 7, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Aquestive Therapeutics Inc.
- Inspection Date
- October 7, 2021
- Product Type
- Drugs
View Company Profile
ID · 3347f17e-d835-4308-b34a-20b08ab74c8e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1153918
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 314.81(b)(2)Timely submission
- 21 CFR 314.80(c)(2)Late submission of quarterly safety reports
- 21 CFR 314.80(c)(2)Interval
- 21 CFR 314.80(b)Failure to develop written procedures
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Other FDA inspections of Aquestive Therapeutics Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 6, 2024 | Not classified | New Jersey District Office |
Other documents for Aquestive Therapeutics Inc.
- FDA Inspection 1257778 - 2024-12-06
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