The FDA has issued warning letters to Olympus Corp. to fix issues it found during inspections at its Japanese facilities.
The FDA has told Olympus Corporation to find solutions for production issues related to its endoscopes after finding several violations at the company’s unit facilities in Japan.
In a series of warning letters issued on January 9, the agency said that Olympus subsidiaries, Olympus Medical System Corporation and Aizu Olympus Company were not meeting requirements for ensuring device quality and performance, including adequate testing and documentation of the assembly process.
It also said that Olympus Medical failed to develop medical device reporting procedures as mandated and did not submit them to the regulator by the required deadlines.
FDA Center for Devices and Radiological Health director Dr. Jeff Shuren said the agency is engaged in “extensive and ongoing efforts" to make Olympus more compliant in endoscope reprocessing.
The first letter was issued in November to Aizu Olympus regarding its endoscope and automated reprocessing equipment manufacturing operations following a July 5-8 inspection at its Fukushima facility.
Among the four potential violations against it were failure to establish and maintain procedures for validating device design; failure to validate the results of a process that could not be fully verified; failure to adequately maintain design history records; and failure to develop, maintain and implement written MDR procedures.
The FDA warned that it could delay premarket approval for Class III devices if it found any quality system regulation violations that were reasonably related to device submissions.
The second letter was sent to Olympus Medical after a September 6-9 inspection of its gastrointestinal and surgical endoscope manufacturing operations in Tokyo.
In addition to not developing proper reporting procedures, the FDA said the company failed to inform it of a device recall, as required by law, that it initiated following complaints that its uretero-reno fiberscope and uretero-reno videoscope were malfunctioning while in use.
Olympus said it would improve its MDR reporting process and train staff, but the FDA said it could not determine the adequacy of this effort until its conclusion.
In a statement, Olympus said healthcare providers do not need to take any corrective actions and should abide by product instructions when using them.
“The company is committed to implementing sustained improvements to its quality system to ensure that we consistently meet requirements and are in full compliance with regulations,” it said.
Olympus has previously been subject to warning letters for testing and manufacturing issues. In 2015, its duodenoscope for diagnosing and treating disorders of the gastrointestinal tract was among solutions linked to a superbug outbreak at U.S. hospitals. Known as CRE, the superbug was resistant to antibiotics and resulted in patient deaths at different hospitals, having been linked to contaminated medical scopes used during endoscopic procedures.
