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Compliance Corner: The 10 Best – And 10 Worst – Things You Can Do When FDA Inspects Your Firm (Part 6)

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 sixth installment of a 10-part series, experts David Elder and John McKay address communication between the front room – where investigators do the majority of their work – and the back room, used by company workers to fulfill investigator requests for documents, records and other information.

Compliance

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 6 of our series is David Elder, executive VP for consulting firm Greenleaf Health, and a former director of the FDA’s Office of Regional Operations within...

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