483
Areva Pharmaceuticals IncAreva Pharmaceuticals Inc – FDA 483, Sep 11, 2025
Record Details
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.
- Office
- Detroit District Office
- Person
View Company Profile
ID · 46f621ae-3fe5-4c81-b4c0-c383d3632512
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.