FDA Inspection 956271 — Nipro Renal Soultions USA, Corporation
The FDA completed an inspection of Nipro Renal Soultions USA, Corporation on January 21, 2016 in Lewisberry, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 21, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Lewisberry, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |