Merit Medical Hit With Warning Letter Over Coating Process

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 South Jordan, Utah-based Merit Medical, 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 the modification during an inspection of the company’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 get additional approval from the FDA,” Merit Medical 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 a result, 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. “Merit takes very seriously its commitment to quality and compliance to applicable regulations, and we intend to work cooperatively with the FDA…” he noted in a prepared statement, adding 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, Lampropoulos emphasized, still will manufacture other products as Merit Medical works to resolve the warning letter.

Founded in 1987, Medrit Medical develops, manufactures and distributes disposable medical products used in interventional and diagnostic procedures in cardiology, radiology and endoscopy. The company employs about 2,300 people worldwide and operates facilities in Salt Lake City and South Jordan, Utah; Angleton, Texas; Richmond, Va.; Rockland, Mass.; Paris, France; Beijing, China, Copenhagen, Denmark; and Maastricht and Venlo, The Netherlands.