FDA Inspection 1113320 — Specialty Blood Center
The FDA completed an inspection of Specialty Blood Center on December 16, 2019 in Charleston, SC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 16, 2019
- Fiscal Year
- 2020
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Charleston, SC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18103 | 21 CFR 630.15(b)(1) | Medical history and physical exam |
| 9234 | 21 CFR 630.40(c) | Notification w/in 8 weeks |
| 9235 | 21 CFR 630.40(c) | Documentation |
| 9263 | 21 CFR 610.40(c)(2) | Device component - labeling |