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Vasca clears FDA warning letter issues:

This article was originally published in Clinica

Executive Summary

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.





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