The FDA warned Merit Medical Systems (NSDQ:MMSI) about distributing an adulterated device after the federal watchdog agency discovered modifications to the coating process for one of Merit’s guidewires.
The FDA inspected one of Merit’s manufacturing facilities in Galway, Ireland, in September 2011, finding that the coating process for the company’s Laureate hydrophilic guidewires had been altered enough that it "could significantly affect the safety or effectiveness of the devices."
That means the device is misbranded, according to the FDA, because the change requires a new pre-market approval application to cover the new process. Merit hadn’t notified the FDA that it planned to introduce a new medical device into the U.S. market, according to 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 to resolve the issues in the warning letter," chairman & CEO Fred Lampropoulos said in prepared remarks. "The FDA warning letter applies only to the Merit Laureate, which represented less than 1% of Merit’s total revenues for 2011."
Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Orthopaedics found itself in a similar position last month when the FDA asked for new PMAs for more than a dozen custom devices or device components that the agency said lacked proper clearance. DePuy responded by halting manufacturing for all custom devices.