FDA Inspection 1070324 — Carter BloodCare
The FDA completed an inspection of Carter BloodCare on Oct 26, 2018 in Frisco, TX. 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 26, 2018
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Frisco, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18082 | 21 CFR 630.10(e)(2) | Additional Medical Assessment Factors |
| 18115 | 21 CFR 630.30(a)(2) | Donor health |
| 227 | 21 CFR 640.4(h) | Storage temperatures after collection |
| 57 | 21 CFR 606.60(a) | Maintain and clean equipment |