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Noven Pharmaceuticals, Inc. MARCS-CMS 479136 —

Noven Pharmaceuticals, Inc.

United States

Issuing Office:

United States



Black HHS-Blue FDA Logo



Office of Pharmaceutical Quality Operations, Division 2
4040 N. Central Expressway, Suite 300
Dallas, Texas 75204 

April 21, 2018


Mr. Jeff Mihm, President and CEO
Noven Pharmaceuticals Inc.
11960 S.W. 144th Street
Miami, Florida 33186-6109

Mr. Mihm:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (FLA-16-21) dated August 5, 2016. Based on our evaluation during the January 18, 2018 through January 26, 2018 inspection of your firm, 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.

If you have any questions regarding this letter, you may contact Jose R. Lopez at JoseR.Lopez@fda.hhs.gov or by phone at (787) 729-8603. In addition, you may contact me at (214) 253-5288.


LCDR John W. Diehl, M.S.
Director, Compliance Branch
Office of Pharmaceutical Quality Operations, Division II 

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