FDA Inspection 1204351 — St Luke's Regional Medical Center
The FDA completed an inspection of St Luke's Regional Medical Center on May 4, 2023 in Boise, ID. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 4, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Boise, ID (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 18038 | 21 CFR 606.100(b) | SOPs for investigations, records |
| 9223 | 21 CFR 606.160(b)(6) | Required records - transfusion reaction and complaints |
| 95 | 21 CFR 606.100(b)(16) | Labeling procedures to avoid labeling mix-ups |