The U.S. Food and Drug Administration (FDA) has issued a warning letter to Merit Medical Systems Inc. over a coating procedure used in the company’s Irish factory.
The FDA, according to the South Jordan, Utah-based firm, cited the firm after noticing a modification of a coating used on the Merit Laureate guidewire, a device designed to help doctors place other medical devices (such as catheters) in blood vessels. Merit Medical makes the guidewire in its Galway, Ireland, facility and ships it to the United States. FDA supervisors noticed themodification during an inspection of thecompany’s facility last fall.
“We made what we believed were minor changes to the product over time, changes that we did not believe required us to getadditional approval from the FDA,” company Chairman and CEO Fred Lampropoulos told The Salt Lake Tribune.
The FDA, however, disagreed, claiming the changes “could significantly affect the safety or effectiveness of the device.” As aresult, the agency deemed Merit Medical’s guidewire adulterated and misbranded, and said it did not have either premarket approval or an investigational device exemption to sell the product. Lampropoulos said his company is working with the FDA to address the organization’s concerns and is hoping to quickly resolve the issues raised in the warning letter. He noted in a prepared statement that the letter applied only to the Laureate guidewires, which represented less than 1 percent of the firm’s total revenue last year. The Galway facility will manufacture other products as Merit Medical works to resolve the warning letter.
Founded in 1987, Merit Medical develops products used in interventional anddiagnostic procedures in cardiology, radiology and endoscopy. The company employs about 2,300 people worldwide.