FDA Inspection 752183 — Medical Center Of The Rockies
The FDA completed an inspection of Medical Center Of The Rockies on Nov 1, 2011 in Loveland, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 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 |