FDA Inspection 680694 — OneBlood, Inc.
The FDA completed an inspection of OneBlood, Inc. on Sep 7, 2010 in Miramar, 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 7, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Miramar, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12202 | 21 CFR 606.170(a) | Adverse Reaction - Investigations |
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 9225 | 21 CFR 606.171 | Biological product deviation report |