FDA Inspection 1131915 — Viant AS&O Holdings, LLC
The FDA completed an inspection of Viant AS&O Holdings, LLC on October 23, 2020 in Orchard Park, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 23, 2020
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Orchard Park, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |