FDA Inspection 1057004 — Specialty Blood Center
The FDA completed an inspection of Specialty Blood Center on June 21, 2018 in Charleston, SC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 21, 2018
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Charleston, SC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 114 | 21 CFR 606.121(c)(1) | Proper name of product |
| 123 | 21 CFR 606.121(c)(4)(i) | Expiration date |
| 18038 | 21 CFR 606.100(b) | SOPs for investigations, records |
| 18040 | 21 CFR 606.160(e)(2) | Cumulative deferral record HIV, HBV, HCV |
| 18067 | 21 CFR 630.5(d) | Emergency medical services |
| 18081 | 21 CFR 630.10(e)(1) | Medical Assessment Factors |
| 18087 | 21 CFR 630.10(f)(3)(i)(B) | Hemoglobin or Hematocrit for male allogeneic donor |
| 18093 | 21 CFR 630.10(g)(1) | Proof Of Identity |
| 18094 | 21 CFR 630.10(g)(2) | Donor's Acknowledgment |
| 9235 | 21 CFR 630.40(c) | Documentation |