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Shelhigh Agrees To Halt Production Of Seized Devices

Law360 (June 22, 2007, 12:00 AM EDT) -- Medical device maker Shelhigh Inc. has agreed to a permanent injunction which will halt distribution of its products until the company’s production processes meet U.S. Food and Drug Administration standards, the regulator said Friday.

The injunction order, filed in the U.S. District Court for the District of New Jersey, comes two months after the FDA seized all of Shelhigh’s medical products, which are used in heart surgery and other procedures, after finding “significant deficiencies” in the company’s manufacturing processes. The FDA said Shelhigh’s production methods compromised...
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