FDA Inspection 1088682 — Carter BloodCare - Texoma
The FDA completed an inspection of Carter BloodCare - Texoma on May 3, 2019 in Sherman, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 3, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Sherman, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 18119 | 21 CFR 630.30(b)(2) | Unsuitable donation - defer testing |