The FDA sent a warning letter to Olympus this month describing a range of violations of federal requirements regarding manufacturing practices—marking the third such letter the medtech giant has received since November.
The letter follows an early November inspection of one of Olympus’ Tokyo facilities, during which the FDA concluded that the devices are “adulterated” due to improper manufacturing practices. Though Olympus sent responses to the FDA’s list of identified issues in December, January and February, and has made some moves to correct those faults, the March 15 letter details the company’s failure to fully address the issues.
In one case, per the FDA, Olympus conducted an analysis of an endoscope end cap that was found to be at risk of falling off while inside a patient’s body and has been the subject of about 160 complaints since late 2020. Olympus didn't implement a corrective action, opting instead to simply monitor future complaints about the device—a response that the FDA deemed “not adequate,” since the faulty end caps could lead to more serious injuries than suggested by the company’s analysis.
Also not up to the agency’s standards are Olympus’ current practices of investigating device complaints: One complaint about the faulty end caps cited by the FDA was filed in November 2020 but not investigated until 2022, despite Olympus’ procedures mandating that investigations begin within a month of receiving a complaint. The FDA said it was “not clear” whether Olympus had thoroughly investigated the reasons for that lapse.
The regulator also said that Olympus has failed to pass on serious complaints about its devices to the FDA. Companies are required to file a report with the FDA within 30 days of learning about a malfunction that could potentially lead to serious injury or death. Olympus has fallen short of this requirement before: In 2018, it pleaded guilty to failing to file reports of serious infections linked to its duodenoscopes and was fined $80 million.
“Olympus’ continued failure to meet FDA requirements demonstrates a troubling disregard for patient safety,” Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, said in an agency announcement Friday.
In a statement sent to Fierce Medtech, Olympus said it “takes this warning letter very seriously,” adding that it plans to submit a “comprehensive response” to the letter within the FDA’s allotted 15-business-day response period.
“As noted in FDA’s warning letter, Olympus has already implemented a number of actions to address the issues identified during the inspection last November. Following receipt of the FDA warning letter, we will further evaluate these actions and, where necessary, will expand those efforts to ensure that our actions fully address the underlying issues that led to the inspectional observations and warning letter,” the statement continued.
“Olympus’ highest priority is providing patients and users with safe and effective medical devices that comply with all applicable legal and regulatory requirements. For that reason, Olympus is committed to addressing the items described in the warning letter in a systemic and comprehensive manner, and to more broadly elevate our global quality system to meet and exceed FDA expectations.”
Prior to this month’s warning letter, the FDA sent two others to Olympus in November and December concerning two of company's manufacturing facilities in Fukushima and Tokyo, respectively. Both letters largely focused on the manufacturing processes for Olympus’ reusable endoscopes, which have to be thoroughly cleaned and sterilized before they can be reused and which have been the subject of several FDA safety notices in recent years.
As the FDA publicized both of the notices earlier this year, Shuren said in a statement that they concerned “violations related to medical device reporting (MDR) requirements and quality system regulations for endoscopes and endoscope accessories.”
“CDRH has been involved in extensive and ongoing efforts with Olympus to address compliance issues related to the reprocessing of endoscopes,” Shuren continued. “However, as described in the recent warning letters, Olympus is not in compliance with MDR reporting and quality system requirements.”
Namely, he said, the company hadn’t met certain quality assurance requirements and had failed to submit medical device reports within required timeframes.