FDA halts foreign inspections as coronavirus spreads

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The FDA is postponing most foreign inspections through April due to the coronavirus outbreak, the agency said March 10. 

The FDA regularly inspects foreign drugmakers, medical devicemakers and manufacturers of other U.S. imported goods. 

The agency cited several reasons for the halt, including that there is a level 4 travel advisory from the State Department, prohibiting travel for all U.S. government employees. 

The FDA said inspections deemed "mission-critical" will be considered on a case-by-case basis.

The agency added it is confident in its ability to maintain oversight of foreign manufacturers using alternative measures that have worked previously.

In the past, when the FDA was unable to conduct physical inspections, it used measures such as denying entry of unsafe products, conducting physical examinations and product sampling at the borders, and using shared information from agreements with foreign governments to ensure product safety. 

The FDA said it is aware that halting foreign inspections could impact its other responsibilities, but that it will be vigilant to monitor the situation closely and try to mitigate potential impacts. It added it is ready to resume inspections as soon as possible. 

"Americans can rest assured the FDA is diligently monitoring this outbreak and the impact to our operations," the agency wrote. 

Read the full news release here

 

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