National Medical Care
This article was originally published in The Gray Sheet
Executive Summary
FDA lifts ban on import of hemodialysis bloodlines manufactured at the W. R. Grace subsidiary's Reynosa, Mexico facility. The ban was rescinded following FDA reinspection of the site "and a commitment by NMC to finish certain studies by May 1994 and, in the interim, to perform additional product final product testing" on an expanded sample base. The firm expects by April 14 to certify its Dublin, Ireland dialyzer facility, also on import alert, clearing the way for reinspection. The NMC facilities were placed on import alert in the summer of 1993 and were cited in a recent consent decree with FDA ("The Gray Sheet" Jan. 24, p. 6)