FDA 483 - AbbVie Inc. - July 02, 2018

An FDA inspection conducted at AbbVie Inc.'s Corporate Headquarters in North Chicago, IL, from May 15 to July 2, 2018, revealed significant issues related to adverse drug experience reporting and data system validation. The primary observation was the failure to report all serious and unexpected adverse drug experiences to the FDA within the mandated 15-calendar-day timeframe. Investigators identified approximately 482 late initial and/or follow-up Individual Case Safety Reports (ICSRs) and 15-Day Alert Reports between October 2014 and May 2018. A notable 119 of these reports were delayed by at least 100 days, with some exceeding 700 days. Products affected included Viekira XR, Venclexta, Technivie, Duopa, Viekira Pak, and Mavyret, with Duopa accounting for approximately 250 late cases. Furthermore, the inspection noted that the computer system used to manage these late ICSRs was not validated and lacked essential security controls, as users were not required to log in with a user ID or password. These findings indicate a systemic breakdown in AbbVie's pharmacovigilance processes, falling short of regulatory expectations for timely and secure adverse event reporting. AbbVie is required to address these observations by implementing corrective actions to ensure compliance with federal reporting regulations.