FDA Inspection 724893 — OneBlood, Inc.
The FDA completed an inspection of OneBlood, Inc. on May 17, 2011 in Cooper City, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- May 17, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Cooper City, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 215 | 21 CFR 640.3(b)(6) | Qualifications of donor - disease transmissible by blood |
| 35 | 21 CFR 606.40 | Clean & orderly |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 80 | 21 CFR 606.100(b)(1) | Donor criteria |