Seized Shelhigh Devices Won't Be Released Yet

A federal judge refused to grant Shelhigh Inc.'s request that the government release the tissue-based devices it seized last month because of concerns about sterility. Judge William Martini said he could not rule whether Shelhigh's devices met GMP standards without holding a hearing, reports the Star-Ledger of Newark, NJ. He said that hearing will come as soon as possible.

May 31, 2007

1 Min Read
Seized Shelhigh Devices Won't Be Released Yet

Shelhigh executives say the company's future is in jeopardy if it cannot export the seized devices.The judge urged both sides to try to reach a settlement, using a mediator if possible. But, as we predicted, Shelhigh has hired Larry Pilot to help in its defense. Companies who seek out Pilot often do so because he is willing to take on FDA in court. Shelhigh also rejected FDA's request to recall devices it already shipped to hospitals. That's not an indicator of being willing to settle, either.  

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