FDA EIR - Allergan Sales, LLC - January 22, 2019

An FDA inspection of Allergan plc's Irvine, CA facility was conducted from January 14-22, 2019, focusing on the company's responsibilities as a sponsor of a pivotal clinical investigation. While no formal FDA 483 inspectional observations were issued, the inspection highlighted several significant discussion items. Key issues identified included deficiencies in financial disclosure and annual reporting. Specifically, ten clinical investigators received substantial consulting payments from Allergan but failed to promptly update their financial disclosure forms or notify the sponsor and Institutional Review Board (IRB). Additionally, Allergan’s 2018 annual report to the FDA omitted protocol deviations related to three serious adverse events that were not reported within the required timeframe. The company's 2017 annual report was also submitted 22 days past its due date, as stipulated by their Investigational Device Exemption (IDE) approval. Allergan management acknowledged these points. They committed to following up with investigators to ensure accurate financial disclosures and stated that corrections would be made to the data listing and reflected in the clinical study report for the omitted serious adverse event deviations. The inspection emphasized the importance of timely and accurate reporting and disclosure in accordance with regulatory expectations for clinical studies.