Battle of Device Maker Shelhigh and FDA Rages On Part I

Newark, NJIn a New Jersey court hearing on May 15, 2007, US District Court Judge William Martini informed medical device maker Shelhigh that it was unlikely that he will allow the release of any inventory seized by US Marshals at its Union City plant, after the FDA found "significant deficiencies in the company's manufacturing processes."

A seizure is an enforcement action taken as a last resort to remove a dangerous product from commerce. The FDA initiates the action by filing a complaint with the District Court where the product is located, and a US marshal is then directed by the court to take possession of the goods until the matter is resolved. The complaint against Shelhigh was filed on April 16, 2007.

The US Marshal did not physically remove the devices from the plant but rather "seized them in place," meaning Shelhigh cannot remove, attempt to remove or in any way interfere with the products without the prior written permission from the US Marshal. The firm's products have also been embargoed by the state of New Jersey.


Also see: Battle of Device Maker Shelhigh and FDA Rages On Part II