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Don’t Call Them Inspections: EUA Holders Shouldn’t Be Surprised If FDA Shows Up To Investigate

 
• By Shawn M. Schmitt

The US FDA is reminding companies with emergency use authorizations for COVID-19 products that the agency has the authority to conduct investigations (but not inspections) of their manufacturing facilities.

Male Knocks on a wooden door with his hand.
• Source: Alamy

The US Food and Drug Administration is reminding holders of emergency use authorizations (EUAs) that they shouldn’t be surprised if an agency investigator knocks on their facility door for a look-see.

“While EUAs have been around for some time, an unparalleled number of EUAs were being considered related to the COVID-19...

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Warning Letters – June 2025

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