FDA Inspection 1100338 — Abaxis Inc
The FDA completed an inspection of Abaxis Inc on August 22, 2019 in Union City, CA. 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
- August 22, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Union City, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3173 | 21 CFR 820.198(d) | Evaluation, timeliness, identification |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |