[podcast]FDA's Foreign Inspections of Drug Manufacturers Have Not Rebounded to Pre-Pandemic Levels
FDA paused many of its in-person inspection efforts during COVID-19 because of travel disruptions and safety concerns. So now that COVID is over, are inspections back to normal?
After pandemic delays, FDA still struggling to inspect foreign drug manufacturers
In the wake of recent deaths from bacteria-tainted eyedrops, a ProPublica analysis of FDA data reveals that the agency inspected only 6% of the overseas plants where drugs and their ingredients are produced in 2022.
FDA halt of foreign inspections may delay some new product approvals
The FDA has decided that the risk of inspectors crossing paths with COVID-19 is greater than the risk to consumers of drugmakers failing to meet FDA standards and putting poor quality drugs on the market. The agency has decided to halt inspections of all foreign drug manufacturers after earlier putting inspections in China on hold.
FDA Postpones All Foreign Inspections Over Coronavirus
As the ongoing COVID-19 outbreak continues to worsen, the U.S. Food and Drug Administration (FDA) announced that it will postpone all foreign inspections, effective immediately.
The agency said it won't conduct inspections of foreign manufacturing facilities until the end of April. However, inspections outside the country that are designated "mission-critical" will still be considered on a case-by-case basis.
Foreign Drug Inspections Decline as FDA Hiring Struggles Continue
The US reliance on imported pharmaceuticals and ingredients is rising as foreign drug facility inspections decreased by about 10% from 2016 to 2018. Part of the reason for the decline: The US Food and Drug Administration (FDA) said it’s still struggling to hire new inspectors.