FDA Seizes Products From Device Maker

Law360, New York (April 18, 2007, 12:00 AM EDT) -- The U.S. Food and Drug Administration seized all medical products from a New Jersey medical device manufacturer over serious concerns that it had compromised the safety and effectiveness of its products, particularly their sterility, the agency said Wednesday.

The seizure of all implantable medical devices from Union, N.J.-based Shelhigh Inc. was made in cooperation with FDA investigators and U.S. Marshals after finding ‚Äúsignificant deficiencies‚ÄĚ in the company's manufacturing processes.

A representative from the company said the raid occurred Tuesday and that there was no advance warning....
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