Gambro AB will continue building a new artificial kidney plant in Opelika, Ala., despite contract difficulties with one of its major customers.
DaVita Inc. of El Segundo, Calif., notified Gambro it was terminating an agreement to source dialysis systems from the Stockholm, Sweden-based firm. DaVita cited import restrictions on Gambro dialysis monitors as the reason for the termination. The Food and Drug Administration issued a warning letter and import alert in January, citing quality-control problems in a Gambro plant in Italy. Gambro has said it expects to rectify the problems by summer.
``As of now there is no change to the plan to open our plant in Opelika,'' Gambro U.S. spokeswoman Anne Bonelli said in a May 31 telephone interview. She said Prismaflex and Phoenix dialysis machines are affected by the FDA warning.
The Opelika operation is due in mid-2008 to begin making dialyzers: fiber-filled filters that act as kidneys during hemodialysis. The 100,000-square-foot plant is scheduled to make about 10 million dialyzers annually. Polymers used to make Gambro's dialyzers are polyarylether sulfone, nylon, polyurethane, polycarbonate and polyvinyl pyrrolidone.
``We negotiated the opening of the Opelika project before we signed the contract with DaVita,'' Bonelli said from Gambro's U.S. headquarters in Lakewood, Colo.
Gambro closed a U.S. dialysis component plant about seven years ago. The closure followed problems with PVC tubing Gambro made in Mexico, but the company maintained that the events were unrelated and that it was restructuring its renal products group.
DaVita is a key U.S. customer for Gambro. Last year it bought Gambro's network of U.S. dialysis clinics and made Gambro its preferred supplier of dialysis systems.
Two Swedish investment firms, Investor AB and Indap AB, have made a takeover offer for Gambro. Gambro is a public company with annual sales of about $2 billion.