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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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IBA Molecular - Close out letter 3/16/11


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

Public Health Service
Food and Drug Administration

Baltimore District Office
Central Region
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779·5454
Fax: (410) 779·5705 

March 16, 2011

Mr. Oliver LeGrain, President
IBA Molecular, Inc.
Chemin Du Cyclotron, 3
1348 Louvain-Ia-Neuve

Dear Mr. LeGrain:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS# 11506 issued October 4, 2008 and the most recent inspection conducted August 11, 2010 at your firm located at 100 Executive Drive, Sterling, VA. Based on the evaluation and inspection, it appears that you have addressed the violation(s) 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.


Randy F. Pack
Director, Compliance Branch


Cc: Mr. Anwer Rizvi, President
IBA Molecular North America, Inc.
21000 Atlantic Blvd.
Suite 730
Dulles, Virginia 20166