FDA EIR - Indivior Manufacturing LLC - August 29, 2019

An FDA inspection of Xellia Pharmaceuticals USA, LLC, located in Raleigh, NC, was conducted from August 27-29, 2019. This initial PADE (Post-marketing Adverse Drug Experience) program inspection focused on the company's reporting activities for three marketed products: Caspofungin acetate for injection, Colistimethate for Injection, and Vancomycin HCI for Injection. The inspection reviewed various documents, including Individual Case Safety Reports (ICSRs), Post-marketing Adverse Drug Evaluation Reports (PADERs), expedited reports, and compliance metrics. The inspection, conducted under the regulatory framework of Compliance Program Guidance Manual CPGM 7353.001 for PADE Reporting, concluded with no significant objectionable conditions or practices observed, and no FDA Form 483 (Inspectional Observations) was issued. The primary issue identified was a discussion item concerning some Individual Case Safety Reports (ICSRs) that had been submitted late to the FDA. At the close-out meeting, management was informed that the inspection report and exhibits would be referred to the Center for Drug Evaluation and Research (CDER) for further review and final classification. Should significant deviations be determined after this review, Xellia Pharmaceuticals would be notified through correspondence or a follow-up inspection. No refusals were encountered, and no samples were collected during the inspection.