FDA Inspection 631322 — Viant AS&O Holdings, LLC
The FDA completed an inspection of Viant AS&O Holdings, LLC on November 20, 2009 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). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 20, 2009
- Fiscal Year
- 2010
- 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 |
| 3141 | 21 CFR 820.150(a) | Storage procedures to prevent mix-ups |
| 3301 | 21 CFR 820.100(a)(2) | Investigation procedures |
| 3303 | 21 CFR 820.100(a)(4) | Verify, validate change {see also 820.100(a)} |
| 3312 | 21 CFR 820.120(d) | Mixups |
| 3687 | 21 CFR 820.100(a)(1) | Analysis of data sources |
| 4169 | 21 CFR 820.100(a)(7) | Identifying relevant info for management review |