FDA Inspection 1031341 — Apira Science, Inc.
The FDA completed an inspection of Apira Science, Inc. on November 7, 2017 in Las Vegas, NV. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 7, 2017
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Las Vegas, NV (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14719 | 21 CFR 820.30(h) | Incorrect translation to production specifications |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |