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U.S. Department of Health and Human Services

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Enforcement Actions

Noven Pharmaceuticals, Inc. - Close Out Letter 10/02/2012

  

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

Public Health Service
Food and Drug Administration
 Los Angeles District
19701 Fairchild
Irvine, California 92612-2506
Telephone (949) 608-2900
Fax          (949) 608-4415

VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED


October 2, 2012


Peter G. Amanatides, Vice President, Quality Assurance and Quality Control
General Manager of the Carlsbad Operations
Noven Pharmaceuticals, Inc.
2732 Loker Avenue West
Carlsbad, CA 92010-6603


Dear Mr. Amanatides:


The Food and Drug Administration has completed an evaluation of your firm's corrective actions in
response to our Warning Letter (WL #54-11, dated August 25, 2011). 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/

Alonza E. Cruse
District Director
Los Angeles District