FDA Inspection 1033975 — Carter BloodCare
The FDA completed an inspection of Carter BloodCare on Dec 6, 2017 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 6, 2017
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Bedford, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 224 | 21 CFR 640.4(f) | Arm preparation |
| 377 | 21 CFR 640.120(a) | Notification to and approval from CBER |
| 78 | 21 CFR 606.100(c) | Record review prior to release |
| 98 | 21 CFR 606.100(c) | Thorough investigations |