FDA Inspection 819069 — BioVision Technologies, LLC
The FDA completed an inspection of BioVision Technologies, LLC on Feb 20, 2013 in Boulder, CO. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Feb 20, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Boulder, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |