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Navinta, LLC MARCS-CMS 498400 —

Navinta, LLC

United States

Issuing Office:

United States



Black HHS-Blue FDA Logo



10903 New Hampshire Avenue
Silver Spring, MD 20993

March 5, 2018


Dr. Mahendra Patel, CEO
Navinta, LLC
1499 Lower Ferry Road
Ewing, NJ 08618‐1414

Dear Dr. Patel:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter dated September 26, 2016 (Ref: 16‐NWJ‐16). Based on our evaluation, it appears that you have addressed the violations contained in the Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its regulations or with other relevant legal authorities. The Agency expects you 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.


LaShanda Long, M.S.
Branch Chief
Postmarketing Safety Branch
Division of Enforcement and Postmarketing Safety
Office of Scientific Investigations
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
Building 51, Room 5356
10903 New Hampshire Avenue
Silver Spring, MD 20993‐0002 

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