FDA Warns Merit Medical Regarding Merit Laureate Hydrophilic Guidewire
February 10, 2012 — The U.S. Food and Drug Administration (FDA) sent a warning letter to Merit Medical Systems Inc. regarding modifications to the hydrophilic coating process for the Merit Laureate Hydrophilic Guidewire, following an inspection of the company's facility in Galway, Ireland.
"Merit takes very seriously its commitment to quality and compliance to applicable regulations, and we intend to work cooperatively with the FDA to resolve the issues in the warning letter," said Fred P. Lampropoulos, Merit's chairman and CEO. "The FDA warning letter applies only to the Merit Laureate, which represented less than 1 percent of Merit's total revenues for 2011."
The company intends to respond to the letter within 15 business days, as required by the FDA. Merit has already begun to resolve the issues that were raised. In the meantime, Merit's Irish facility remains fully functional for all other products.
For more information: www.merit.com