FDA Inspection
Aquestive TherapeuticsAquestive Therapeutics – FDA Inspection, Apr 3, 2015
Record Details
This FDA Inspection record concerns Aquestive Therapeutics, with an inspection on April 3, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Aquestive Therapeutics
- Inspection Date
- April 3, 2015
- Product Type
- Drugs
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ID · 3b4e1336-a4d5-42ba-8de2-d6f9423c261d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 921152
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(3)Weight or measure of sample
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.22(d)Procedures not in writing, fully 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 | |
| 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 |
| October 23, 2008 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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