FDA Inspection 1247483 — Carter BloodCare - Texoma
The FDA completed an inspection of Carter BloodCare - Texoma on August 23, 2024 in Sherman, TX. 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
- August 23, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Sherman, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15030 | 21 CFR 606.60(b) | Equipment calibration frequency |
| 18093 | 21 CFR 630.10(g)(1) | Proof Of Identity |
| 35 | 21 CFR 606.40 | Clean & orderly |
| 57 | 21 CFR 606.60(a) | Maintain and clean equipment |