Med News Today

New Jersey Company's Medical Devices Seized

Shelhigh, Inc. of Union, NJ, has had its medical devices seized by the FDA. The company will fight the order in federal court.

April 22, 2007 -- U.S. Food and Drug Administration (FDA) investigators and U.S. Marshals recently seized all implantable medical devices from Shelhigh, Inc. after FDA inspectors claimed significant deficiencies in the company's manufacturing processes that may compromise the safety and effectiveness of the products, particularly their sterility. Shelhigh denies all FDA claims upon which the seizure was based and intends to challenge the decision in Federal Court (07 Civ 1769 WJM, New Jersey).

"I am deeply disappointed by the FDA decision which was made after the full cooperation of Shelhigh during an intensive 10 week inspection of our facility by the FDA," said Shelhigh founder and Chief Scientific Officer, Shlomo Gabbay, M.D. "During this inspection Shelhigh fully addressed all observations raised by FDA personnel, repeatedly requested corrections of statements made by the FDA in their site report, and also repeatedly requested meetings with the FDA to discuss any outstanding issues as well as concerns which arose during the 10 week inspection, and these meetings were also refused by the FDA."

posted by nattietodd @ 8:49 AM