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Compliance Corner: The 10 Best – And 10 Worst – Things You Can Do When FDA Inspects Your Firm (Part 3)

A 10-part Compliance Corner series

 
• By Shawn M. Schmitt

A panel of longtime industry experts offer manufacturers a list of things they should and shouldn’t do when an investigator from the US agency knocks on their facility door. In this third installment of a 10-part series, the experts address the do’s and don’ts of responding to investigator requests for information and records.

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A panel of longtime industry experts recently convened to give manufacturers advice on the 10 best and worst things they could do during an inspection by the US Food and Drug Administration.

Offering tips in Part 3 of our series is Steve Niedelman, lead quality systems and compliance consultant at the law firm King & Spalding, who worked at the FDA for...

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