FDA Inspection 738690 — OneBlood, Inc.
The FDA completed an inspection of OneBlood, Inc. on Aug 5, 2011 in Tallahassee, 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
- Aug 5, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Tallahassee, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15030 | 21 CFR 606.60(b) | Equipment calibration frequency |
| 3452 | 21 CFR 601.12(b) | Major changes to an approved application |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |