FDA 483 - Boehringer Ingelheim Pharmaceuticals, Inc. - September 11, 2025

An FDA inspection of Boehringer Ingelheim Pharmaceuticals, Inc. in Ridgefield, CT, identified a significant issue regarding their clinical trial sponsor responsibilities. The firm failed to adhere to its Trial Statistical Analysis Plan by not excluding data associated with important protocol deviations from supplementary analyses. This oversight may compromise the integrity and reliability of the clinical trial data and results.