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U.S. Department of Health and Human Services

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Enforcement Actions

DAVA International Inc. Close out Letter 3/22/11

  

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

Public Health Service
Food and Drug Administration
 

Silver Spring, MD 20993 


March 22, 2011


John Klein
Chief Executive Officer
Dava International Inc.
Parker Plaza
400 Kelby Street, 10th Floor
Fort Lee, New Jersey 07024


Dear Mr. Klein:


The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter dated October 13, 2009. 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/
Michael M. Levy, Jr., Esq.
Director
Division of New Drugs and Labeling Compliance
Office of Compliance
Food and Drug Administration