FDA Warns CPM Contract Pharma for Flouting GDUFA Facility Fee

The FDA has issued its first warning letter to a manufacturer that failed to self-identify and pay its facility fees as mandated by GDUFA. The warning to Germany’s CPM Contract Pharma reiterates the agency’s intent to enforce compliance with the user fee law’s requirements and comes just weeks after the FDA began posting a list of sites that have failed to submit their annual facility fees on time.
Washington Drug Letter