FDA Inspection 865201 — Blood Assurance, Inc.
The FDA completed an inspection of Blood Assurance, Inc. on Jan 17, 2014 in Abingdon, VA. 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 17, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Abingdon, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 208 | 21 CFR 640.3(a)(1) | Donor suitability procedures not followed |
| 370 | 21 CFR 640.72(a)(2) | Donor exams, tests, lab data, interviews |
| 80 | 21 CFR 606.100(b)(1) | Donor criteria |