FDA Warns Blood Sugar Device Maker, LifeScan Given 15 Days To Respond About Why It Did Not Investigate Complaints

A letter from Barbara J. Cassens, a District Director with the US Food and Drug Administration, has warned LifeScan, Inc., of deficiencies within its OneTouch Ultra and OneTouch UItraSmart Blood Glucose Meters manufacture and distribution.

Citing five different complaints that did not receive a response or complete investigation, Cassens' December 7 letter to LifeScan's Chairman Eric P. Milledge said that "...our investigators determined that you are manufacturing the OneTouch Ultra and the OneTouch UltraSmart Blood Glucose Meters in violation of the Federal Food, Drug, and Cosmetic Act (the Act)." Cassens' letter also gave the company 15 "working" days to respond to the allegations. It was unclear how the Christmas holiday would impact that date, if at all. Regardless, the deadline for any such response is imminent if not already passed.

Neither the FDA nor (shockingly) LifeScan has any information following-up this issue on their web sites.

This is not the first time that LifeScan has run afoul of the FDA. According to a March 2001 issue of IVD Technology, the company was "ordered to pay a criminal fine of $29.4 million and an additional $30.6 million in civil penalties, damages, attorneys' fees, and restitution to the U.S. government." LifeScan was also reportedly placed on probation for three years.

MedicineNet.com says that LifeScan estimates that 4.7 milion diabetics use the company's devices to monitor their blood sugar -- the key measurement that almost every medical person agrees is critical to reducing long-term health risks and complications associated with diabetes.

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posted by Consumer Help Web Editorial Team at 3:53 PM |