1009371
3D Imaging Drug Design and Development LLC — FEI 3009143510
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 20, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Little Rock, AR (United States)
Citations
| ID | CFR | Description |
|---|
| 17741 | 21 CFR 212.30(b) | Equipment not clean |
| 17749 | 21 CFR 212.30(a) | Prevention of contamination |
| 17763 | 21 CFR 212.20(d) | Determination need for investigation |
| 17764 | 21 CFR 212.20(e) | Written QA procedures established, followed |
| 17778 | 21 CFR 212.40(c) | Use of reliable suppliers |
| 17812 | 21 CFR 212.50 | Adequate controls (general) |
| 17814 | 21 CFR 212.50(b) | Master Production and Control Records |
| 17857 | 21 CFR 212.60(f) | Lab written procedures |
| 17932 | 21 CFR 212.60(b) | Testing Procedures- Conformance to Standards |
| 6730 | 21 CFR 314.80(b) | Failure to develop written procedures |