Tag Archives: Freedom of Information

Who can see Form FDA 483s, and where do I get them?

Previously, we talked a bit about what the big deal is about these Form FDA 483s.  Today, we talk about how to get a hold of actual 483 reports and who else can see them.  This is where things get a little more tricky.  Theoretically, Form FDA 483s are public information and, thus, available through the FDA’s Freedom of Information Act Office.  So, any Form FDA 483 can be requested by anyone. Continue reading