Inspections, Compliance, Enforcement, and Criminal Investigations
Innovative Directions in Health Close out Letter 2/10/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Silver Spring, MD 20993-0002|
February 10, 2011
Dr. Khalid Mahmud
4005 W 65th Street, Suite 212
Edina, MN 55435
Dear Dr. Mahmud:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter dated April 5, 2010. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA follow-up 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.
Michael M. Levy, Jr., Esq.
Division of New Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research