Vasca clears FDA warning letter issues:
This article was originally published in Clinica
Vasca, which develops the LifeSite haemodialysis access system, says it has resolved issues relating to a November 2001 warning letter from the FDA. Earlier this month, the Tewksbury, Massachusetts-based company became the subject of a lawsuit relating to the warning letter as well as sales of the product (see Clinica No 1019, p 13). The FDA says the company has taken appropriate corrective action, including making a labelling change for the product.