Boehringer Ingelheim pharmaceuticals news
The U.S. District Court for the Northern District of Ohio approved a consent decree of permanent injunction restraining Boehringer's Ben Venue Laboratories Inc. company from manufacturing and distributing drugs from its Bedford, Ohio, facility until FDA determines that its operations are compliant with the Food, Drug and Cosmetic Act (FDCA). The agency filed the decree after FDA inspections found several product quality problems, including particles in some sterile products and basic facility cleaning and maintenance issues. FDA said that "poorly maintained equipment deteriorated to the point that it shed particles into injectable drugs." Ben Venue has agreed to adhere to a strict timetable to bring the facility under compliance or face "substantial" fines. ...