CDER Compliance Chief Explains What Makes a ‘Bad Actor’

Did you know that when your company recalls a product you could technically get arrested for violating the 1938 FD&C Act? “Basically anyone in a responsible relation to a violation of the FD&C [Act] is technically in violation of the law,” said Howard Sklamberg, director of CDER’s Office of Compliance. But while the FD&C Act offers a wide theoretical criminal liability, there are a variety of factors that the FDA uses to determine who to criminally prosecute.
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