FDA Inspection 841483 — OneBlood, Inc.
The FDA completed an inspection of OneBlood, Inc. on Jul 24, 2013 in Lantana, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 24, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Lantana, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 208 | 21 CFR 640.3(a)(1) | Donor suitability procedures not followed |
| 9097 | 21 CFR 600.15 | Blood & Blood Components |