FDA Inspection 1246370 — Specialty Blood Center
The FDA completed an inspection of Specialty Blood Center on August 14, 2024 in Charleston, 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
- August 14, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Charleston, SC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18044 | 21 CFR 610.40(a)(2) | Test for HTLV, syphilis, West Nile, Chagas |
| 18068 | 21 CFR 630.5(d) | CPR certification |
| 18103 | 21 CFR 630.15(b)(1) | Medical history and physical exam |
| 78 | 21 CFR 606.100(c) | Record review prior to release |
| 9238 | 21 CFR 630.40(b)(3) | Results of testing |