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Biomedical Research Institute of America dba BioMed IRB - Close Out Letter 01/16/2013

  

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

Public Health Service
Food and Drug Administration
 Center for Biologics Evaluation and Research
1401 Rockville Pike
Rockville, MD 20852-1448

January 16, 2013


Fred Fox, Executive Director
Biomedical Research Institute of America dba BioMed IRB
7676 Hazard Drive
San Diego, California 92108


Dear Mr. Fox:


The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CBER-12-03 dated March 29, 2012. 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/

Mary A. Malarkey, Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research