FDA Inspection 784663 — OneBlood, Inc
The FDA completed an inspection of OneBlood, Inc on May 11, 2012 in Vero Beach, FL. 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
- May 11, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Vero Beach, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 208 | 21 CFR 640.3(a)(1) | Donor suitability procedures not followed |
| 227 | 21 CFR 640.4(h) | Storage temperatures after collection |
| 238 | 21 CFR 640.11(a) | General requirements - storage |