FDA EIR - Horizon Pharma Inc - US Operations - June 06, 2017

An FDA inspection of Horizon Pharma Inc.'s Lake Forest, IL facility was conducted from May 9 to June 6, 2017. This inspection focused on Postmarketing Adverse Drug Experience (PADE) Reporting, aligning with CDER's performance goals and Compliance Program 7353.001A for postmarketing safety reporting, ensuring adherence to 21 CFR requirements. Horizon Pharma is a specialty biopharmaceutical distributor of prescription human drug products. Significantly, no FDA-483 (Inspectional Observations) was issued, and no discussion items were communicated to company management, indicating a compliant status. The inspection confirmed that the company had successfully corrected two previous issues identified during a 2014 inspection. These earlier items involved refining the main Adverse Drug Experience (ADE) reporting procedure to include global references and clearer guidance for 15-day follow-up reports, and accurately detailing the 3-day timeframe for NDA Field Alert Reports. Although three instances of late 15-Day Alert submissions were noted, the firm provided sufficient justification through its investigations. Ultimately, no new violations or mandatory actions were identified during this inspection, affirming the company's compliance with adverse drug experience reporting regulations.