FDA EIR - Boehringer Ingelheim Pharmaceuticals, Inc. - September 01, 2010

An FDA inspection of Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) in Danbury, CT, was conducted from August 23 to September 1, 2010. This joint FDA/European Medicines Agency inspection focused on BIPI's sponsor and monitor responsibilities for a specific clinical trial supporting a new drug submission. The inspection identified three significant observations, documented on a Form FDA 483. First, BIPI failed to formally document the transfer of obligations to three contract research organizations in writing before the clinical trial commenced, violating 21 CFR 312.52(a). Second, there was a failure to ensure proper study monitoring, as an approved Trial Monitoring Manual was not provided to monitoring staff prior to trial initiation, and instances of undocumented monitoring visits at a clinical site were noted. Furthermore, an approved Event Adjudication Committee Charter was not established before case reviews began, which is a breach of 21 CFR 312.50. Third, the company did not ensure foreign clinical research complied with ethical principles and local regulations (21 CFR 312.120(c)). Specifically, vital status information was collected from subjects who withdrew consent at foreign sites without documented Ethics Committee approval. BIPI acknowledged these observations at the exit discussion and committed to providing written responses, which were subsequently submitted on September 14 and 16, 2010, detailing corrective actions.