Attached files
| file | filename |
|---|---|
| 8-K - NEPHROS INC | form8-k.htm |
 |
DEPARTMENT OF HEALTH AND HUMAN SERVICES |
| Food and Drug Administration | |
| New Jersey District Office | |
| Central Region | |
| Waterview Corporate Center | |
| 10 Waterview Blvd. 3rd Floor | |
| Parsippany, New Jersey 07054 | |
| Telephone: (973) 331-4900 | |
| FAX: (973) 331-4969 |
April 07, 2016
VIA UNITED PARCEL SERVICE
Mr. Daron G. Evans, President & CEO
Nephros, Inc.
41 Grand Avenue
River Edge, New Jersey 07661-1947
Dear Mr. Evans:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (15-NWJ-05), dated May 27, 2015. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
| /s/ Craig W. Swanson | |
| Craig W. Swanson | |
| Acting District Director | |
| New Jersey District |
| 1 |