Boehringer Ingelheim responds to FDA warning letter


22 May 2013

Boehringer Ingelheim responds to FDA warning letter


Ingelheim, 22 May 2013 – Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) has issued a warning letter concerning its manufacturing practices following an agency inspection in Ingelheim, Germany in November 2012. The matter also concerned foreign particles detected in batches of active pharmaceutical ingredients.

"Boehringer Ingelheim is taking this issue very seriously and is fully committed to working with the FDA on a comprehensive action plan that addresses the FDA's concerns, ensuring that it implements corrective and preventive actions to optimise its quality systems. We are committed to compliance with current Good Manufacturing Practices requirements. We will invest all our energy to remedy the situation in order to meet all FDA requests, building on the experience gained from all 22 inspections successfully passed at the Ingelheim site in the last 5 years by different authorities around the world, other than the latest FDA inspection in November" said Dr Gerhard Koeller, Head of Corporate Division Quality at Boehringer Ingelheim.

Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 140 affiliates and more than 46,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim's endeavors.

In 2012, Boehringer Ingelheim achieved net sales of about 14.7 billion euro. R&D expenditure in the business area Prescription Medicines corresponds to 22.5% of its net sales.