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  5. Heritage Pharmaceuticals, Inc. - 12/28/2016
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Heritage Pharmaceuticals, Inc.

Heritage Pharmaceuticals, Inc.

United States

Issuing Office:

United States



Black HHS-Blue FDA Logo



New Jersey District
Waterview Corporate Center
10 Waterview Blvd. 3rd Floor
Parsippany, NJ 07054
Telephone: (973) 331-4900
FAX: (973) 331-4969 

December 28, 2016


Dr. Fakrul Sayeed, Interim CEO
Heritage Pharmaceuticals, Inc.
12 Christopher Way Ste 300
Eatontown, NJ 07724-3331

Dear Dr. Sayeed:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 16-NWJ-01 issued on 11/5/2015. 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.


Stephanie Durso
Acting Director Compliance Branch
New Jersey District

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