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Does the FDA give you a chance to state your case before initiating report of Criminal Violation?

In general the FDA commissioner does give the manufacturer notice and an opportunity to present information and views to show cause why criminal prosecution should not be recommended to a United States attorney.

They are not required to do so if they a) expect that the manufacturer will try to destroy evidence or flee or, b) if further investigation is required by the Department of Justice.

For more information see FDA’s Enforcement Policy