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COMPANY SOPs TO PROTECT AGAINST FDA CRIMINAL INVESTIGATION

This article was originally published in The Tan Sheet

Executive Summary

COMPANY SOPs TO PROTECT AGAINST FDA CRIMINAL INVESTIGATION should be developed in advance to prevent employees from waiving their Fourth Amendment rights against illegal search and seizure, attorney John Fleder advised at a Food & Drug Law Institute conference June 23. "Have a lawyer develop and help implement standard operating procedures and other written guidance advising the employees" what actions to take when approached by FDA investigators, either at the form or at their homes, Fleder suggested.

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