FDA Inspection 905362 — Nephros, Inc.
The FDA completed an inspection of Nephros, Inc. on October 24, 2014 in Whippany, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 24, 2014
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Whippany, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 749 | 21 CFR 803.52(b)(3) | Date of Event |