FDA Inspection 850756 — The Blood Connection, Inc.
The FDA completed an inspection of The Blood Connection, Inc. on Sep 30, 2013 in Piedmont, SC. 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). 7 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 30, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Piedmont, SC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15030 | 21 CFR 606.60(b) | Equipment calibration frequency |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 77 | 21 CFR 606.100(b) | Written SOPs available for use by personnel |
| 9223 | 21 CFR 606.160(b)(6) | Required records - transfusion reaction and complaints |
| 9225 | 21 CFR 606.171 | Biological product deviation report |
| 95 | 21 CFR 606.100(b)(16) | Labeling procedures to avoid labeling mix-ups |
| 98 | 21 CFR 606.100(c) | Thorough investigations |