FDA Inspection 694671 — Carter BloodCare
The FDA completed an inspection of Carter BloodCare on Oct 15, 2010 in Flower Mound, 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 15, 2010
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Flower Mound, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 67 | 21 CFR 606.65(e) | Following manufacturer's instructions |
| 9288 | 21 CFR 640.21(a) | Eligibility of platelet donors |
| 98 | 21 CFR 606.100(c) | Thorough investigations |