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: Michael Carter’s bLAWg

FDA Seizes All Medical Products From N.J. Device Manufacturer for Significant Violations

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(April 18, 2007) U.S. Food and Drug Administration (FDA) investigators and U.S. Marshals seized all implantable medical devices from Shelhigh, Inc., Union, N.J., after finding significant deficiencies in the company's manufacturing processes. The deficiencies may compromise the safety and effectiveness of the products, particularly their sterility.

Full post as published by Michael Carter’s bLAWg on January 30, 2008 (boomark / email).

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