FDA Inspection 752183 — Medical Center of the Rockies
The FDA completed an inspection of Medical Center of the Rockies on November 1, 2011 in Loveland, CO. 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
- November 1, 2011
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Loveland, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 150 | 21 CFR 606.151(e) | Procedures to maintain records of emergency transfusions |
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 215 | 21 CFR 640.3(b)(6) | Qualifications of donor - disease transmissible by blood |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |