News about GMP/cGMP

13.03.2020

FDA: Foreign Inspections postponed due to Coronavirus

The US FDA announced that it is postponing most foreign inspections through April with immediate effect due to the Coronavirus disease. Inspections outside the US that are considered critical will be reviewed by the FDA on a case-by-case basis.

The decision is based on a travel ban for government employees issued by the Center for Disease Control and Prevention. The FDA further states that a supervision of international manufacturers and imported products will be provided by alternative measures.

The resumption of foreign inspections will be resumed as soon as possible.


Source:

FDA: Press Release



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