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Compliance Corner: Don’t Sign (Or Even Hear) That Affidavit!

 
• By Shawn M. Schmitt

Device makers presented with an affidavit by the US FDA during a facility inspection should walk away as quickly as possible, King & Spalding partner Jessica Ringel advises.

Jigsaw puzzle with word compliance

If you’re presented with an affidavit by a US Food and Drug Administration investigator during a facility inspection, don’t sign it. In fact, don’t even listen to it being read aloud.

That’s advice from Jessica Ringel, a partner in the Washington, DC, office of law firm King & Spalding. She says device makers can land in hot water with the agency...

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