1099045
Stickman Dialysis Industries, LLC — FEI 3012706378
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 8, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Arundel, ME (United States)
Citations
| ID | CFR | Description |
|---|
| 21425 | 21 CFR 820.184(f) | DHR - UDI not included |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |