Boehringer Ingelheim Announces Successful Resolution of FDA Warning Letter

Boehringer Ingelheim has announced that by a letter dated 2 June, the 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."