inforMED

What is FDA actually citing device makers for?

An industry-wide view of inspection citations, classifications, and compliance actions — built for procurement, regulatory, and quality teams doing supplier due diligence.

Citations5,824
Inspections6,161
Compliance actions144
Import refusals10,544
Firms inspected596

Inspection outcomes

All inspections on file

No Action Indicated (NAI)3,737
Voluntary Action Indicated (VAI)2,147
Official Action Indicated (OAI)277

Compliance actions

Warning letters and injunctions

Warning Letter140
Injunction4