FDA Inspection 668081 — OneBlood, Inc.
The FDA completed an inspection of OneBlood, Inc. on June 18, 2010 in Thomasville, GA. 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
- June 18, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Thomasville, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 205 | 21 CFR 640.3(f) | Donations in less than eight weeks |
| 31 | 21 CFR 606.20(b) | Qualifications of responsible personnel |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |