FDA Inspection 1187284 — Carter BloodCare at Hulen
The FDA completed an inspection of Carter BloodCare at Hulen on October 28, 2022 in Fort Worth, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 28, 2022
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Fort Worth, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18096 | 21 CFR 630.10(g)(2)(ii) | Donor's Acknowledgment - Exculpatory language |