FDA Warns Abbott Unit Over Glucose Monitors

Law360, New York (July 21, 2010, 5:23 PM EDT) -- The U.S. Food and Drug Administration has warned an Abbott Laboratories subsidiary that quality control procedures are lacking in the manufacture of two of the company's blood glucose measuring devices.

In an inspection earlier in 2010, FDA investigators found that Abbott Diabetes Care Inc.'s FreeStyle glucose monitoring and Navigator continuous monitoring systems were adulterated, in violation of the Federal Food, Drug and Cosmetic Act, the agency said in a letter released Monday and dated July 2.

Investigators, who visited Abbott's Alameda, Calif., facilities between Feb. 8...
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