FDA Inspection
Nephros, Inc.Nephros, Inc. – FDA Inspection, Nov 13, 2013
Record Details
This FDA Inspection record concerns Nephros, Inc., with an inspection on November 13, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Nephros, Inc.
- Inspection Date
- November 13, 2013
- Product Type
- Devices
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ID · 2d3390ec-f6a4-4488-85a5-88f0b734cdcd
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 851457
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
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 |
| October 24, 2014 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Nephros, Inc.
- FDA Inspection 967762 - 2016-02-22
- FDA Inspection 905362 - 2014-10-24
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