1147134
Medlink Imaging, LLC — FEI 2433615
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 26, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Pine Brook, NJ (United States)
Citations
| ID | CFR | Description |
|---|
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3665 | 21 CFR 820.20(b)(3) | Management representative |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |