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

During an inspection conducted from September 4 to September 11, 2025, the Food and Drug Administration (FDA) issued a Form 483 to Boehringer Ingelheim Pharmaceuticals, Inc. The primary observation related to the company's sponsor responsibilities for clinical trial protocols. Specifically, the firm failed to ensure an investigation was conducted in accordance with its general investigational plan and protocols, as required by the Investigational New Drug (IND) application. A key issue identified was the company's failure to adhere to its Trial Statistical Analysis Plan (TSAP) concerning the exclusion of data for important protocol deviations (iPDs). Multiple iPDs were not reconciled or uploaded into the clinical data repository prior to database lock. Consequently, the initial Clinical Trial Report (CTR) included supplementary analyses that incorrectly retained data that should have been excluded, due to the unavailability of complete iPD information. Although iPD data later became available, subsequent revisions of the CTR did not repeat the supplementary analyses to rectify the omissions. This oversight in following predetermined statistical analysis procedures may have compromised the integrity and reliability of the clinical trial data and results. The company is expected to address these observations to ensure compliance with regulatory standards for clinical investigations.