Boston gets back on track as Irish plant in the clear
This article was originally published in Clinica
Executive Summary
Following a seven-day US FDA inspection of Boston Scientific's Galway, Ireland-based factory, the agency has reported that no observations were made at the facility where the company's Taxus Express2 drug-eluting stent (DES) is manufactured. The inspection was carried out as part of the ongoing investigation into the worldwide recall of nearly 100,000 Taxus DESs throughout July and August. The FDA has already given Boston's other DES plant in Maple Grove, Minnesota the all-clear when it inspected the facility in July.