Boehringer resolves FDA manufacturing facility concerns

German family-owned pharma major Boehringer Ingelheim said today that it has been notified by a letter from the US Food and Drug Administration of the agency’s 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 drugmaker stated.

Earlier this year, the  FDA issued a complete response letter for the New Drug Application of the investigational sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin. This referenced previously-observed deficiencies at a Boehringer Ingelheim facility where empagliflozin will be manufactured. At that time, the FDA stated these deficiencies need to be resolved before the approval of the application.