FDA Inspection 764488 — Intermountain Health Saint Joseph Hospital
The FDA completed an inspection of Intermountain Health Saint Joseph Hospital on Jan 26, 2012 in Denver, CO. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jan 26, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Denver, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 205 | 21 CFR 640.3(f) | Donations in less than eight weeks |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 78 | 21 CFR 606.100(c) | Record review prior to release |
| 89 | 21 CFR 606.100(b)(10) | Controlling storage temperatures |
| 9235 | 21 CFR 630.40(c) | Documentation |