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Luitpold Pharmaceuticals, Inc.

Luitpold Pharmaceuticals, Inc.

United States

Issuing Office:

United States


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

 US Food & Drug Administration
New York District Office
158-15 Liberty Avenue
Jamaica, New York 11433-1034

August 21, 2015

Mary Jane Helenek, M.S., RPh.
President and CEO
Luitpold Pharmaceuticals, Inc.
One Luitpold Drive
Shirley, New York 11967

Dear Ms. Helenek:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter NYK-2011-33 dated August 31, 2011. 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.



Lillian C. Aveta
Compliance Officer
New York District 

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