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Boehringer Ingelheim Corporation Fixes Factory Issues, Clearing Way For New Approval Request


6/4/2014 7:01:07 AM

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Boehringer Ingelheim Announces Successful Resolution of FDA Warning Letter

Ingelheim, June 3, 2014 – Boehringer Ingelheim today announced that by a letter dated June 2, the United States Food and Drug Administration ("FDA") has informed the Company about the closure of the Warning Letter that was issued for its Ingelheim, Germany, manufacturing facility.

After concluding its recent inspection in March and considering the Company's response with supportive documentation, the FDA determined the quality management and compliance systems of the facility to be acceptable.

"The successful lifting of the Warning Letter is a measure of the progress we have made toward improving our quality systems and manufacturing processes," said Dr Gerhard Koeller, Head of Corporate Division Quality at Boehringer Ingelheim. "We will continue to maintain and further improve our quality systems to provide products of the highest possible standards to patients."

Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 142 affiliates and a total of more than 47,400 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.

Taking social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects, such as the initiative "Making more Health" and caring for the employees. Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability.

In 2013, Boehringer Ingelheim achieved net sales of about 14.1 billion euros. R&D expenditure corresponds to 19.5% of its net sales.

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