FDA Inspection 1267736 — Primary Children's Hospital - Miller Campus
The FDA completed an inspection of Primary Children's Hospital - Miller Campus on Apr 24, 2025 in Lehi, UT. 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 24, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Lehi, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 61 | 21 CFR 606.60(a) | Provide proper equipment to meet requirements |
| 9225 | 21 CFR 606.171 | Biological product deviation report |
| 9456 | 21 CFR 610.60(a) | Full label |