FDA EIR - Exelixis, Inc. - September 27, 2012

An FDA inspection of Exelixis, Inc. was conducted from September 10 to September 27, 2012, marking the company's initial Good Clinical Practice (GCP) FDA inspection. The inspection, carried out under the Bioresearch Monitoring Compliance Program, focused on Exelixis's sponsor responsibilities for clinical study Protocol XL 184-301. The regulatory framework emphasized compliance with sponsor obligations, specifically 21 CFR 312.56(b).

The inspection revealed significant violations, primarily a failure to promptly ensure that investigators complied with study agreements, the general investigational plan, and applicable regulatory requirements. Key issues included persistent problems at Clinical Site 3908 with inadequate source documentation for adverse events, concomitant medications, and patient eligibility, which remained unaddressed for approximately one year. This site also exhibited instances of subjects receiving incorrect study drug dosing and informed consent deficiencies. Clinical Site 1315 showed recurring inadequate source documentation for a specific subject over an extended period. These observations indicated a failure in the sponsor's responsibility to properly monitor the study and ensure adherence to the protocol.

Michael M. Morrissey, PhD, President and Chief Executive Officer, acknowledged the observations and committed to submitting a written response to the FDA 483 within 15 business days to address the identified deficiencies.