NMC efforts to get Dublin facility import ban lifted targeted by grand jury.
This article was originally published in The Gray Sheet
Executive Summary
NMC MANUFACTURING DOCUMENTATION AT DUBLIN FACILITY likely is being targeted by a New Jersey grand jury in its ongoing investigation of National Medical Care's Dublin, Ireland, manufacturing plant. In a "target letter" received by the company Feb. 9, the U.S. Attorney for the District of New Jersey indicates that the investigation is exploring possible criminal law violations related to NMC's effort to convince FDA to lift a January 1991 import ban on devices made at the Dublin facility. The target letter cites federal rules prohibiting firms from making false submissions to the government.