FDA Inspection 1153918 — Aquestive Therapeutics Inc.
The FDA completed an inspection of Aquestive Therapeutics Inc. on Oct 7, 2021 in Warren, NJ. 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
- Oct 7, 2021
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Warren, NJ (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 6730 | 21 CFR 314.80(b) | Failure to develop written procedures |
| 6830 | 21 CFR 314.80(c)(2) | Interval |
| 6831 | 21 CFR 314.80(c)(2) | Late submission of quarterly safety reports |
| 8912 | 21 CFR 314.81(b)(2) | Timely submission |