FDA Stops Olympus Devices From Entering the US

FDA stops Olympus devices from entering the US

The agency said it issued the import alerts because it “continues to have concerns related to outstanding Quality System regulation violations by Olympus.”

U.S. Blocks Olympus Medical Device Shipments After Repeated Violations

The agency said Olympus has yet to address compliance issues.

FDA blocks select Japanese-made Olympus medical devices from US imports over quality violations - US and Global News

The U.S. Food and Drug Administration (FDA) has issued to health care providers a letter announcing import alerts on select Olympus Medical Systems Corporation devices manufactured in Japan. The subsidiaries as well as Olympus manufacture the affected devices. This action follows the agency’s finding of outstanding violations of Quality System regulations at Olympus’s Aizu manufacturing facility, despite Olympus’s efforts to remedy earlier defic…