FDA Inspection 597253 — Intermountain Health Lutheran Hospital
The FDA completed an inspection of Intermountain Health Lutheran Hospital on July 1, 2009 in Wheat Ridge, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 1, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Wheat Ridge, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12202 | 21 CFR 606.170(a) | Adverse Reaction - Investigations |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 65 | 21 CFR 606.65(c) | Testing of representative samples of reagent lots |