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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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VanderVeer Center - Close Out Letter 7/26/11

  

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

Public Health Service
Food and Drug Administration
 

Silver Spring, MD 20993-0002


 

July 26, 2011


Dr. Elizabeth VanderVeer
VanderVeer Center
6650 SW Redwood Lane, Suite 150
Portland, OR 97224

Dear Dr. VanderVeer:


The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter dated November 18, 2010. Based on our evaluation, it appears that you have addressed the violations 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.


Sincerely,

/s/


Judith McMeekin, Pharm.D.
Acting Director
Division of Prescription Drugs
Office of Unapproved Drugs & Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research