FDA Inspection 1007580 — Versiti Blood Health, Inc
The FDA completed an inspection of Versiti Blood Health, Inc on March 17, 2017 in Indianapolis, IN. 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: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 17, 2017
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Indianapolis, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 57 | 21 CFR 606.60(a) | Maintain and clean equipment |
| 98 | 21 CFR 606.100(c) | Thorough investigations |