FDA Inspection 716130 — St. Mary's Regional Hospital
The FDA completed an inspection of St. Mary's Regional Hospital on March 18, 2011 in Grand Junction, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 18, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Grand Junction, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 251 | 21 CFR 640.25(b) | Quality control |
| 253 | 21 CFR 640.25(b)(4) | Corrective action |
| 67 | 21 CFR 606.65(e) | Following manufacturer's instructions |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 89 | 21 CFR 606.100(b)(10) | Controlling storage temperatures |
| 98 | 21 CFR 606.100(c) | Thorough investigations |