FDA Inspection 662001 — The Blood Connection
The FDA completed an inspection of The Blood Connection on May 7, 2010 in Greenville, SC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 7, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Greenville, SC (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 |