FDA Inspection 745871 — OneBlood, Inc.
The FDA completed an inspection of OneBlood, Inc. on December 19, 2011 in Fort Lauderdale, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 10 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- December 19, 2011
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Fort Lauderdale, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 142 | 21 CFR 606.140(a) | Establishment of spec., standards, and test procedures |
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 159 | 21 CFR 606.160(a)(1) | Legibility and indelibility |
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 31 | 21 CFR 606.20(b) | Qualifications of responsible personnel |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 78 | 21 CFR 606.100(c) | Record review prior to release |
| 9225 | 21 CFR 606.171 | Biological product deviation report |
| 9234 | 21 CFR 630.40(c) | Notification w/in 8 weeks |
| 98 | 21 CFR 606.100(c) | Thorough investigations |