FDA Inspection 797930 — The Blood Connection, Inc.
The FDA completed an inspection of The Blood Connection, Inc. on April 13, 2012 in Greenwood, SC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 13, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Greenwood, SC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12202 | 21 CFR 606.170(a) | Adverse Reaction - Investigations |
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 165 | 21 CFR 606.170(a) | Adverse reaction - Maintenance of Reports |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |