FDA Inspection
Aquestive TherapeuticsAquestive Therapeutics – FDA Inspection, Sep 13, 2012
Record Details
This FDA Inspection record concerns Aquestive Therapeutics, with an inspection on September 13, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Aquestive Therapeutics
- Inspection Date
- September 13, 2012
- Product Type
- Drugs
View Company Profile
ID · 9bcf174b-bc47-49b8-b59c-1c980e1278e7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 800838
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.110(a)Written in-process control procedures
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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 |
| 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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