FDA Inspection 800838 — Aquestive Therapeutics
The FDA completed an inspection of Aquestive Therapeutics on Sep 13, 2012 in Portage, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 13, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Portage, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |