The Food and Drug Administration (FDA) has postponed all routine domestic facility inspections as a result of the coronavirus outbreak.
This news follows the FDA’s announcement that most overseas visits would be paused temporarily. These decisions aim to protect both inspectors and companies from the coronavirus.
In a statement the FDA commented: “Protecting the health and safety of our staff and their families is of paramount concern to the U.S. FDA. As a nation we must do everything we can to help slow the spread of the virus and help flatten the curve of the COVID-19 pandemic.”
Typically, the FDA performs routine inspections of domestic manufacturers of medical devices and other products every few years. The exact schedule is determined via risk analysis. However, currently during the coronavirus pandemic it has been decided that the benefits of these inspections no longer outweigh the risks. Although in certain circumstances the FDA comments that the inspections will, “proceed if mission-critical.
Stephen Hahn, FDA commissioner, is looking at alternative ways to conduct inspections that do not risk putting staff and the companies they visit at risk. The FDA statement explained: “This can include, among other things, evaluating records in lieu of conducting an onsite inspection on an interim basis when travel is not permissible, when appropriate.”
Last year, the domestic violation rate was reportedly around 5%. The FDA explained how this low figure shows how companies "understand and appreciate their shared responsibility to ensure the integrity of the supply chain."
The FDA plans to “resume any postponed inspections as soon as feasible,” however, it may be some time before the situation is sufficiently under control for the inspection programme to get back to normal.
