OCPNF - Olympus says addressing FDA concerns on endoscope production

Japanese medical device maker Olympus Corp ( OTCPK:OCPNF ) ( OTCPK:OCPNY ) said Wednesday that the company was taking corrective action to address the concerns raised by the U.S. FDA regarding the production of endoscopes.

During surgeries and diagnostic procedures, endoscopes allow doctors to visualize and access human internal organs such as the urinary tract, gastrointestinal tract, and respiratory tract.

On Monday, the agency disclosed the warning letters sent to Olympus units Olympus Medical System Corp and Aizu Olympus Co public in December and November, respectively.

According to the FDA, during inspections of sites in Tokyo and Fukushima, the subsidiaries of Olympus (OCNPF) were not meeting its requirements for quality assurance and performance of endoscopes.

In an email to Reuters late Wednesday, Olympus (OCNPF) said that responses to each of the FDA’s warning letters had been submitted and actions to fix the issue were in progress.

During the first half of FY23, Olympus (OCNPF) reported ¥173.5B profit on ¥552B revenue from its Endoscopic Solutions Division.

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