FDA Inspection 833367 — Versiti Blood Health, Inc
The FDA completed an inspection of Versiti Blood Health, Inc on April 19, 2013 in Indianapolis, IN. 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: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 19, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Indianapolis, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9225 | 21 CFR 606.171 | Biological product deviation report |
| 94 | 21 CFR 606.100(b)(15) | Schedules and procedures for equipment & calibration |