PDA Letter Article

U.S. FDA Rep Offers Overview on Visible Particulates

by Rebecca Stauffer, PDA

PDA VI Course 2008 065 edit

Although the number of recalls due to visible particulates in injectable drug products peaked in 2014 (1), the U.S. FDA remains concerned about the risks of visible particulates. CDER Chemist Hailin Wang, PhD, provided an overview of FDA’s views on the topic in her talk “Regulatory Perspective on Inspection of Injectable Products for Visible Particulates,” in the first plenary of the 2019 PDA Visual Inspection Forum, April 23, in Washington, D.C.