FDA Inspection 790050 — OneBlood, Inc.
The FDA completed an inspection of OneBlood, Inc. on Jul 9, 2012 in Tavernier, 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 9, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Tavernier, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 227 | 21 CFR 640.4(h) | Storage temperatures after collection |
| 238 | 21 CFR 640.11(a) | General requirements - storage |