FDA 483 - Areva Pharmaceuticals Inc - September 11, 2025

An FDA inspection of Areva Pharmaceuticals Inc in Georgetown, IN, revealed significant issues with regulatory reporting and pharmacovigilance procedures. The firm failed to submit annual reports and periodic adverse drug experience reports (PADERs) in a timely manner, with some PADERs being entirely missing. Additionally, written procedures for evaluating and reporting post-marketing adverse drug experiences, including the use of third-party vendors, were found to be insufficiently detailed.