FDA 483 - Boehringer Ingelheim Pharmaceuticals, Inc. - December 12, 2019

An FDA inspection of Boehringer Ingelheim Pharmaceuticals, Inc. in Ridgefield, CT, identified significant deficiencies in their role as a sponsor of clinical investigations. The firm failed to notify the FDA of clinical investigators terminated for cause and did not ensure investigations adhered to the general investigational plan and protocols. Additionally, the company failed to retain required Data Monitoring Committee meeting minutes for the specified period.