FDA Inspection 680990 — Montrose Memorial Hospital Blood Bank
The FDA completed an inspection of Montrose Memorial Hospital Blood Bank on September 17, 2010 in Montrose, CO. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 17, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Montrose, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 117 | 21 CFR 606.121(f) | Labeling of blood products unsuitable for transfusion |
| 167 | 21 CFR 606.170(b) | Adverse reaction - fatality |
| 215 | 21 CFR 640.3(b)(6) | Qualifications of donor - disease transmissible by blood |
| 46 | 21 CFR 606.40(a)(6) | Provide space for quarantine of unsuitable for use items |
| 67 | 21 CFR 606.65(e) | Following manufacturer's instructions |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9078 | 21 CFR 600.12(a) | Maintenance - tracing |
| 9596 | 21 CFR 640.3(a) | Donor suitability by means of medical history |