USA – OAI Classifications for Drug, Device Facilities Decline Sharply Over Last 5 Years, FDA Data Show

As the spotlight on foreign drug and medical device facilities brightens because of impurity concerns and a lack of US Food and Drug Administration (FDA) staff abroad, the total number of Official Action Indicated (OAI) classifications continued to fall in 2019, and US-based facilities still saw the lion’s share.

A look into FDA’s inspection classification database for the drug, device and biologic centers reveals how China and India’s share of the overall OAI classifications total has remained relatively steady over the past five years, while the US has seen a declining number of such classifications…