FDA EIR - AbbVie Inc. - July 02, 2018

An FDA inspection of AbbVie Inc.'s North Chicago, IL facility was conducted from May 15 to July 2, 2018. This was a routine surveillance inspection focused on Post-Marketing Adverse Drug Experience (PADE) Reporting Regulations, initiated by CDER's Office of Scientific Investigations under Compliance Program 7353.001. The inspection identified significant issues concerning the timely reporting of adverse drug experiences. The primary violations included the late submission of approximately 482 initial and/or follow-up Individual Case Safety Reports (ICSRs) to the FDA between October 2014 and May 2018. Some of these reports were delayed by over 100 days. Furthermore, the computer system used to track these late ICSRs was found to be unvalidated and lacked essential security features, such as mandatory user IDs and passwords. The inspection also noted deficiencies in the firm's training program for users of its adverse event management system, with many personnel having access without completing required training. At the inspection's conclusion, a one-point FDA-483 Inspectional Observations was issued, detailing these deficiencies. AbbVie Inc. management acknowledged the observations and committed to providing a written response within 15 business days, outlining corrective actions. The ongoing corrective and preventive actions for training issues are expected to be verified in a subsequent inspection.