Shelhigh Seizure Likely to Be Upheld

Shelhigh Inc., which had its inventory of tissue-based implants seized by the government because of concerns over sterility, has gone to court to get them back, but the judge says he's not inclined to grant the company's wish, reports the Star-Ledger of Newark. The firm argues that it should be allowed to ship the products overseas because GMPs don't apply to products made for export. U.S. District Judge William J.

May 16, 2007

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Martini said he does not agree with that interpretation, but is giving Shelhigh more time to collect additional evidence. The company says it will likely be forced out of business if it can't sell the seized product.Update: On May 18 FDA issued a preliminary public health advisory about possible contamination of Shelhigh devices.

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