FDA Inspection 1164657 — Hendrick Regional Laboratory Transfusion Services
The FDA completed an inspection of Hendrick Regional Laboratory Transfusion Services on March 10, 2022 in Abilene, 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
- March 10, 2022
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Abilene, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 9225 | 21 CFR 606.171 | Biological product deviation report |