FDA Sends Warning Letter To Abbott Diabetes Unit

July 20, 2010

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The Food and Drug Administration (FDA) warned Abbott Laboratories’ (ABT) diabetes unit about manufacturing violations involving the company’s blood-glucose-monitoring systems, according to a report published on NASDAQ.com.

The July 2 letter stemmed from a March inspection of an Abbott Diabetes Care Inc. facility in Alameda, Calif., that makes the FreeStyle glucose-monitoring and the Navigator continuous-monitoring systems. The devices are used by people with diabetes to monitor their blood-glucose, or blood-sugar levels. The letter was posted to FDA’s website Tuesday.

The FDA said the company failed to follow proper quality-control testing and inspection procedures when correcting problems such as scratches found on some FreeStyle Lite monitoring strips.

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