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Compliance Corner: Listen To 'DRUM' Beat When Writing An After-Inspection Response To FDA, Expert Says

 
• By Shawn M. Schmitt

Longtime device industry insider Steve Niedelman shares some best practices for drafting an effective response letter to US FDA following an unfavorable facility inspection.

Jigsaw puzzle with word compliance

Drafting an effective response letter to US FDA following an unfavorable facility inspection is as easy as "listening to the 'DRUM' beat," a longtime industry expert says.

Steve Niedelman, lead quality systems and compliance consultant at the law firm King & Spalding, explained that a well-written post-inspection...

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