FDA Warns Abbott To Fix 'Adulterated' Devices

By Erin Fuchs

Law360, New York (November 17, 2009, 4:16 PM ET) -- The U.S. Food and Drug Administration has warned Abbott Laboratories to remedy six violations related to its in vitro diagnostic products, describing the devices as adulterated under federal law.

In a letter dated Aug. 12 but not released by the agency until Tuesday, the FDA outlined the six violations at Abbott's diagnostic unit in Des Plaines, Ill.

The violations relate to devices used to diagnose, treat, cure or prevent disease and stem from two FDA investigators' inspection of the Des Plaines facility between June 2 and...
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