FDA Inspection 1009371 — 3D Imaging Drug Design and Development LLC
The FDA completed an inspection of 3D Imaging Drug Design and Development LLC on April 20, 2017 in Little Rock, AR. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Drugs.
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 |