FDA Inspection 819652 — OneBlood, Inc.
The FDA completed an inspection of OneBlood, Inc. on February 21, 2013 in Hollywood, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 21, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Hollywood, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 31 | 21 CFR 606.20(b) | Qualifications of responsible personnel |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9044 | 21 CFR 600.10(b) | Personnel capabilities |
| 98 | 21 CFR 606.100(c) | Thorough investigations |