Tags: China | Coronavirus | fda | fda inspections

FDA Stops Overseas Inspections Through April

fda sign is shown outside of its buildings
(AP)

By    |   Wednesday, 11 March 2020 02:19 PM

The coronavirus outbreak has caused the U.S. Food and Drug Administration to stop most overseas inspections for food, drug and medical devices through April, CNBC has reported.

 “We are aware of how this action may impact other FDA responsibilities, including product application reviews,” FDA Commissioner Stephen Hahn said in a statement. “We will be vigilant and monitor the situation very closely and will try to mitigate potential impacts from this outbreak."

Hahn said the move was necessary due to the State Department banning government employees from traveling, as well as other nations restricting the entrance of foreign visitors.

Inspections already had been halted in China and India, the two countries where almost 80 percent of ingredients for generic medicines are produced, according to The New York Times.

China drug supply expert Rosemary Gibson told the Times that a lack of FDA oversight is worrying, saying that “At a time when there are shortages of medicines - critical medicines - there’s a lot of untoward activity that can take place, like counterfeits and poor quality products. The bottom line is, who is going to be checking?”

Center for Science in the Public Interest Deputy Director Sarah Sorscher added to the Times that “The FDA has always struggled to meet its foreign food inspection targets, and this is going to set them back even further.”

However, Hahn tried to assuage concerns, saying inspections also were not possible in the past, and the agency will use such techniques as sampling products at the U.S. border and checking companies that have had a history of weak compliance, The Hill reported.

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The coronavirus outbreak has caused the U.S. Food and Drug Administration to stop most overseas inspections for food, drug and medical devices through April, CNBC has reported.
fda, fda inspections
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2020-19-11
Wednesday, 11 March 2020 02:19 PM
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