FDA Inspection 678421 — UCH-MHS
The FDA completed an inspection of UCH-MHS on September 3, 2010 in Colorado Springs, CO. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 16 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 3, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Colorado Springs, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 155 | 21 CFR 606.160(b) | Required records |
| 246 | 21 CFR 640.25(a) | Storage temps./agitation |
| 253 | 21 CFR 640.25(b)(4) | Corrective action |
| 31 | 21 CFR 606.20(b) | Qualifications of responsible personnel |
| 3443 | 21 CFR 610.47 | Notification of transfusion recipients |
| 3618 | 21 CFR 606.100(b)(19) | Procedure for HIV or HCV lookback |
| 67 | 21 CFR 606.65(e) | Following manufacturer's instructions |
| 75 | 21 CFR 606.100(a) | SOP compliance |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 84 | 21 CFR 606.100(b)(5) | Accurate measurement of quantity of blood |
| 89 | 21 CFR 606.100(b)(10) | Controlling storage temperatures |
| 9086 | 21 CFR 600.14(a)(1) | Who must report - manufacturer |
| 9238 | 21 CFR 630.40(b)(3) | Results of testing |
| 9271 | 21 CFR 610.41 | Donor Deferral - reentry |
| 98 | 21 CFR 606.100(c) | Thorough investigations |