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Merck Sharp & Dohme Corp. - Close Out Letter 2/1/13


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

Public Health Service
Food and Drug Administration
Office of Compliance
Office of Scientific Investigations


1 February 2013


Merck Sharp and Dohme Corp.
Attention: Lou Ann Eader, Ph.D.
Director, Worldwide Regulatory Affairs
P.O. Box 1000, UG2C-50
North Wales, PA 19454-1099

Dear Dr. Eader:

This letter concerns Merck Sharp and Dohme’s Warning Letter dated February 17, 2012, which was issued by the Office of Scientific Investigations. In your Warning Letter, you were notified of your failure to demonstrate good cause for noncompliance of section 505(o)(3), of the Food, Drug and Cosmetic Act (the Act) [21 U.S.C. 355], with regard to postmarketing requirement (PMR) 1602/1603 for Januvia and Janumet.

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter: 12-HFD-47-02-01 dated February 17, 2012. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter.

This letter does not relieve you from the responsibility of taking all necessary steps to assure sustained compliance with the Act and its implementing regulations or with other relevant legal authority. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Should you have any questions or concerns regarding this letter, please contact Hee (Sheila) Lianos, OSI PMR Coordinator, by letter at the following address:

 Food and Drug Administration
 CDER/Office of Compliance
 ATTENTION: OSI PMR Coordinator, Hee Lianos, RPh, PharmD
 10903 New Hampshire Avenue
 Building #51, Room 5337
 Silver Spring, MD 20993


{See appended electronic signature page}

Thomas Moreno
Acting Office Director
Office of Scientific Investigations
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

This is a representation of an electronic record that was signed
electronically and this page is the manifestation of the electronic
Reference ID: 3272486