FDA Inspection 1164656 — Hendrick Regional Blood Center
The FDA completed an inspection of Hendrick Regional Blood Center on Mar 7, 2022 in Abilene, 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
- Mar 7, 2022
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Abilene, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18038 | 21 CFR 606.100(b) | SOPs for investigations, records |
| 18092 | 21 CFR 630.10(f)(6)(ii) | Physical Assessment Determination - Skin Examination |
| 18093 | 21 CFR 630.10(g)(1) | Proof Of Identity |
| 18108 | 21 CFR 630.15(b)(3) | Weight |
| 41 | 21 CFR 606.40(a)(1) | Provide space for examination |