FDA Inspection 1093994 — Oklahoma Blood Institute
The FDA completed an inspection of Oklahoma Blood Institute on Jun 7, 2019 in Oklahoma City, OK. 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
- Jun 7, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Oklahoma City, OK (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 18048 | 21 CFR 606.145(a) | Control risk of contamination |
| 18053 | 21 CFR 606.145(d) | Infection in bloodstream |
| 18082 | 21 CFR 630.10(e)(2) | Additional Medical Assessment Factors |
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |
| 9262 | 21 CFR 610.40(b) | One or more approved screening tests |
| 98 | 21 CFR 606.100(c) | Thorough investigations |