January 12, 2023

FDA issues warning letters to endoscope manufacturer

By: Judy Mathias

Editor's Note

The Food and Drug Administration (FDA) on January 10 announced that it had recently issued two warning letters to Olympus Medical Systems Corporation and one of its subsidiaries, Aizu Olympus Co, Ltd, after facility inspections.

The letters addressed violations related to medical device reporting (MDR) requirements and quality system regulations for endoscopes and accessories, including surgical and GI endoscopes and automated endoscope reprocessors, the FDA says.

During recent inspections, the FDA’s Center for Devices and Radiological Health, determined that Olympus did not meet requirements to ensure the quality and performance of the devices, such as adequate testing and documentation of the device assembly process, in addition to not developing MDR procedures and not submitting MDRs within the required timeframes.

The FDA says it will continue to ensure that Olympus fully addresses the violations covered in the warning letters.


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