FDA Inspection 1113325 — Aquavit Life Sciences, Inc.
The FDA completed an inspection of Aquavit Life Sciences, Inc. on December 19, 2019 in Las Vegas, NV. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 19, 2019
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Las Vegas, NV (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3269 | 21 CFR 820.80(b) | Incoming acceptance records, documentation |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3671 | 21 CFR 820.25(a) | Personnel |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |