Medical device contractor settles FCA allegations based on TAA violations

On Thursday, 8 August 2019 the U.S. Department of Justice (DOJ) announced that Danish medical device company Ambu Inc. (Ambu) will pay US$3.3 million to settle False Claims Act (FCA) allegations that it violated the Trade Agreements Act (TAA) (19 U.S.C. § 2518) by selling products to the Defense Logistics Agency (DLA) and the Department of Veterans Affairs (VA) that were made in China and Malaysia.

The TAA restricts the federal government's purchase of "end products" to only those (1) manufactured in the United States or wholly manufactured in a "designated country," or (2) "substantially transformed'' in the United States or a designated country. China and Malaysia are not designated countries.

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