FDA EIR - AbbVie Inc. - December 15, 2021

An FDA surveillance inspection of AbbVie Inc. in North Chicago, IL, was conducted from December 8-15, 2021. This high-priority inspection, under Compliance Program 7348.810 for Sponsors and Contract Research Organizations, focused on three clinical protocols supporting a PDUFA BLA Supplemental application. The inspection comprehensively reviewed sponsor activities, including investigator selection, monitoring, quality assurance, safety reporting, and data management.

While no Form FDA 483 was issued, the inspection highlighted an issue regarding the monitoring of primary endpoint data accuracy. Specifically, numerous data entry errors for Crohn's Disease Activity Index (CDAI) scores and related components, such as data and body weight measurements, were observed across multiple clinical sites. These discrepancies were identified after the protocol-specified 12-week primary efficacy endpoint.

AbbVie's management acknowledged the findings and committed to addressing these issues through process improvements. The FDA indicated that the observed conditions would undergo further review by the agency and could potentially be considered violations of the FD&C Act, with the report forwarded to CDER for final classification.