The recent controversy surrounding the abrupt resignations of W.R. Grace Chairman J. Peter Grace and Chief Executive Officer J.P. Bolduc has overshadowed equally serious problems occurring at National Medical Care, a healthcare subsidiary of Grace.
For the second time in two years, NMC, a Waltham, Mass.-based dialysis company, has been cited by the Food and Drug Administration for violating regulations related to the importation of dialysis equipment manufactured at its plant in Dublin, Ireland.
The FDA issued an alert last month after receiving complaints from four patients who said a chemical used to sterilize NMC dialysis equipment made them ill. NMC manufactures dialysis equipment and bloodlines, and operates nearly 600 freestanding kidney dialysis centers worldwide.
In a March 22 letter to Constantine Hampers, M.D., NMC's founder and chairman, the FDA said it would bar the company from importing devices manufactured by the Dublin plant until several quality-control violations are corrected.
"Given the serious nature of these violations*.*.*.*all devices manufactured by NMC in Dublin, Ireland, will be re-fused entry into the United States until these violations are corrected," the FDA letter states.
Grace has said it expects to resolve the problem by the second quarter of 1995. Company officials declined further comment. FDA officials couldn't be reached.
In June 1993, the FDA temporarily banned NMC from importing hemodialysis bloodlines and dialysis machines manufactured by its plants in Reynosa, Mexico, and Dublin. The FDA cited the dialysis provider with violating the Federal Medical Device Good Manufacturing Practice Regulations and subsequently blocked the import of NMC products to the United States (Aug. 16, 1993, p. 22).
NMC entered into a consent decree with the FDA in 1994 to improve some of the quality-control issues related to the manufacturing and importation of its dialysis equipment. The company said it has since cleared up the problems in its Reynosa plant.
Nonetheless, the news couldn't come at a worse time for the Boca Raton, Fla.-based company.
Last month, Grace was thrown into the public spotlight after the company revealed that CEO Bolduc's resignation was related to allegations that he sexually harassed several female employees. Bolduc vehemently denied those charges.
Shortly after Bolduc's departure, J. Peter Grace, its longtime chairman, resigned amid a shareholder dispute.
NMC Chairman Hampers is a leading candidate to replace Bolduc as CEO.
Meanwhile, the company last week declined to speculate about the future of its healthcare division, despite recent published reports that it may consider spinning off one of its subsidiaries to improve its debt rating.
The division-which includes NMC-also provides home infusion, home respiratory therapy and home health services. It generated $1.9 billion in 1994 revenues, up 24% from 1993.