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CLOSEOUT LETTER

ID Biomedical Corp., a subsidary of GSK Biologicals Nov 16, 2015

ID Biomedical Corp., a subsidary of GSK Biologicals - Close Out Letter 11/16/15


ID Biomedical Corp., a subsidary of GSK Biologicals

  

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

 
 Food and Drug Administration
Silver Spring MD 20993

NOV 16 2015

Mr. John Glavas
Site Director, Quebec Operations
GSK Biologicals, North America
2323 du Parc Technologique Blvd
Quebec City, Quebec, Canada G1P 4R8

Dear Mr. Glavas:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter [CBER-14-03]. 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


cc: Kimber Poffenberger, Ph.D.
     VP, Head of NA Regulatory Affairs
     GlaxoSmithKline Vaccines
     2301 Renaissance Blvd., Mailcode RN0210
     King of Prussia, PA 19406