FDA Inspection
Nephros, Inc.Nephros, Inc. – FDA Inspection, Oct 24, 2014
Record Details
This FDA Inspection record concerns Nephros, Inc., with an inspection on October 24, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Nephros, Inc.
- Inspection Date
- October 24, 2014
- Product Type
- Devices
View Company Profile
ID · 7a9348ea-3c89-431f-95b1-dc06fea0b866
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 905362
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 803.52(b)(3)Date of Event
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.50(a)(1)Documented evaluation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Nephros, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 22, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 13, 2013 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Nephros, Inc.
- FDA Inspection 967762 - 2016-02-22
- FDA Inspection 851457 - 2013-11-13
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