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  5. Boehringer Ingelheim Pharma GmbH & Co KG - 06/05/2014
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Boehringer Ingelheim Pharma GmbH & Co KG

Boehringer Ingelheim Pharma GmbH & Co KG

United States

Issuing Office:

United States


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

Public Health Service
Food and Drug Administration
 Office of Manufacturing and Product Quality
Division International Drug Quality
International Compliance Branch
10903 New Hampshire Avenue
Building #51, Room 4248
Silver Spring, MD 20993

TELEPHONE: (301) 796-3196
                  FAX: (301) 847-8742


June 5, 2014

Dr. Gerd Konzen, Sr. Vice President LPSG
Boehringer Ingelheim Pharma GmbH & Co KG
Binger Strasse 173
55216 Ingelheim am Rhein, Germany

Dear Dr. Konzen:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 320-13-015, dated May 6, 2013. Based on our evaluation, 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.




Regina T. Brown
Senior Policy Advisor

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