FDA Inspection 1009371 — 3D Imaging Drug Design And Development LLC
The FDA completed an inspection of 3D Imaging Drug Design And Development LLC on Apr 20, 2017 in Little Rock, AR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 20, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Little Rock, AR (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
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 |