Compliance Communications Blog

"A Primer in What Not to Do"


The US Department of recently filed suit against a pharmaceutical company and its founder, owner and Chairman of the Board for violations to the Federal Food, Drug and Cosmetic Act (FD&CA) by manufacturing and distributing “adulterated and misbranded medical devices.”  By itself, DOJ’s decision isn’t groundbreaking news but...the charges leveled against the company and its executive creates a blueprint of how many ways there are to violate the FD&CA.  For companies in the life sciences industry, the DOJ’s charges offer some insight into the actions that are likely to translate into serious enforcement action.

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