FDA Closes Out Warning Letter for Boehringer Ingelheim Manufacturing Facility

Boehringer Ingelheim reports that in a letter dated June 2, 2014, FDA has informed the company about the closure of the Warning Letter that was issued for its Ingelheim, Germany, manufacturing facility.

The company explained that after concluding its recent inspection in March 2014 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 Gerhard Koeller, Head of Corporate Division Quality at Boehringer Ingelheim, in a company statement. “We will continue to maintain and further improve our quality systems to provide products of the highest possible standards to patients.”

The FDA had issued the company a Warning Letter in May 2013.

In March 2014, the FDA issued a complete response letter for the new drug application for the investigational sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin, an antidiabetes medication developed as part of the diabetes alliance between Boehringer Ingelheim and Eli Lilly. The complete response letter referenced previously observed deficiencies at a Boehringer Ingelheim facility where empagliflozin will be manufactured. The FDA stated these deficiencies needed to be resolved before the approval of the application.

Source: Boehringer Ingelheim

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