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  5. N.V.E. Pharmaceuticals, Inc. - 02/21/2017
  1. Warning Letters

CLOSEOUT LETTER

N.V.E. Pharmaceuticals, Inc.

Recipient:
N.V.E. Pharmaceuticals, Inc.

United States

Issuing Office:

United States

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
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

February 21, 2017

Mr. Robert Occhifinto, President and Owner
NVE Pharmaceuticals, Inc.
15 Whitehall Road
Andover, New Jersey 07821

Dear Mr Occhifinto:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter, file number 13-NWJ-11. Based on our evaluation, it appears that you have addressed the violations 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/

Stephanie Durso
Acting Director of Compliance
New Jersey District

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