Merits Health clears FDA hurdle

Tuesday, February 5, 2013

CAPE CORAL, Fla. – Merits Health says the U.S. Food and Drug Administration (FDA) has cleared its manufacturing facility in Taiwan.

In a letter dated Jan. 30, the FDA states: “The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our warning letter. Based on our evaluation, it appears that you have addressed the violations contained in this warning letter.”

In a warning letter dated Nov. 11, 2011, the FDA notified Merits Health of eight violations concerning manufacturing and processes at the facility.

The FDA states that it will continue to monitor Merits Health’s compliance.

“This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means,” the FDA states.

Merits Health says its lifts, wheelchairs and scooters are now in the process of being removed from the FDA’s “import alert” watch list.