FDA swoops on tissue firm amid sterility concerns
This article was originally published in Clinica
Executive Summary
The FDA last week raided the Union, New Jersey plant of tissue-based implant manufacturer Shelhigh, after finding faults in the company's manufacturing processes that could have contaminated the products and result in their potential failure. Among the products seized are paediatric heart valves and conduits, surgical patches, dural patches, annuloplasty rings and arterial grafts. The devices have been available on the market since 1997 - the total number that could be contaminated is not known.