FDA Inspection 736481 — Carter BloodCare
The FDA completed an inspection of Carter BloodCare on Jul 27, 2011 in Bedford, 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). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 27, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Bedford, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 207 | 21 CFR 640.3(a) | Donor suitability not performed on day of collection |
| 208 | 21 CFR 640.3(a)(1) | Donor suitability procedures not followed |
| 291 | 21 CFR 640.56(d) | Potency level - corrective action |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 98 | 21 CFR 606.100(c) | Thorough investigations |