Gambro Dialysis Systems Cited For QSR Violations In FDA Warning Letter
This article was originally published in The Gray Sheet
A recent FDA warning letter following up on inspections of four Gambro Healthcare facilities, conducted in the wake of a May-June Class I recall of the Cobe Centrysystem 3 blood tubing sets, maintains that the firm's dialysis device quality system regulation violations "are symptomatic of serious underlying problems."
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