FDA Inspection
Aquestive TherapeuticsAquestive Therapeutics – FDA Inspection, Oct 23, 2008
Record Details
This FDA Inspection record concerns Aquestive Therapeutics, with an inspection on October 23, 2008, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Aquestive Therapeutics
- Inspection Date
- October 23, 2008
- Product Type
- Drugs
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ID · 2b79e2f4-ddbc-4722-a0dd-5fc6d3c2dee4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 544288
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Aquestive Therapeutics
5| Date | Classification | Office | Project area |
|---|---|---|---|
| January 30, 2025 | Not classified | Detroit District Office | |
| April 3, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 13, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 28, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 23, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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