FDA Inspection 921152 — Aquestive Therapeutics
The FDA completed an inspection of Aquestive Therapeutics on Apr 3, 2015 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 3, 2015
- Fiscal Year
- 2015
- 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 |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4408 | 21 CFR 211.194(a)(3) | Weight or measure of sample |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |