FDA Inspection 770193 — UCH-MHS
The FDA completed an inspection of UCH-MHS on March 1, 2012 in Colorado Springs, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 28 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 1, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Colorado Springs, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 101 | 21 CFR 606.110(a) | Supervision of qualified physician |
| 102 | 21 CFR 606.110(a) | Written certification |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 12203 | 21 CFR 606.170(a) | Adverse Reaction- Reports of Investigations |
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 155 | 21 CFR 606.160(b) | Required records |
| 158 | 21 CFR 606.160(e)(1) | Donor deferral record - each location |
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 208 | 21 CFR 640.3(a)(1) | Donor suitability procedures not followed |
| 224 | 21 CFR 640.4(f) | Arm preparation |
| 227 | 21 CFR 640.4(h) | Storage temperatures after collection |
| 241 | 21 CFR 640.11(b) | General requirements - inspection |
| 253 | 21 CFR 640.25(b)(4) | Corrective action |
| 3245 | 21 CFR 640.61 | Explanation of hazards |
| 3246 | 21 CFR 640.61 | Obtaining consent in an appropriate manner |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 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 |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |
| 9234 | 21 CFR 630.40(c) | Notification w/in 8 weeks |
| 9235 | 21 CFR 630.40(c) | Documentation |
| 9243 | 21 CFR 630.40(a) | Notification |
| 9596 | 21 CFR 640.3(a) | Donor suitability by means of medical history |
| 98 | 21 CFR 606.100(c) | Thorough investigations |