FDA issues third warning letter to Olympus for failure to rectify endoscope complaints
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The FDA has issued a warning letter to Olympus Medical over their manufacturing of endoscopes and endoscope accessories following an inspection of their Tokyo facility in Japan.
This is the third warning letter from the FDA following two separate letters issued to Olympus at the end of 2022.
According to the letter, the inspection which occurred Nov. 7, 2022, through Nov. 10, 2022, revealed that the devices were “adulterated,” meaning the methods, facilities or controls used for, their manufacture, packing, storage, or installation were not “in conformity with the current good manufacturing practice requirements of the Quality System regulation.”
The FDA noted it received responses from Seiji Morishita, Olympus director, on Dec. 5, 2022, Jan. 10, 2023 and Feb. 13, 2023.
According to the letter, Olympus failed to establish and maintain procedure for the implementation of corrective and preventive action including analyzing processes, work operations, concessions, quality audit reports, quality records, service records, and complaints. Additionally, the FDA reported the company failed to ensure it reviewed and assessed the process after changes or process deviations occurred and conducted revalidation when appropriate.
The agency also alleged that Olympus failed to establish and maintain procedures for receiving, reviewing and evaluating complaints by a formally designated unit.
According to the warning letter, Olympus had received nearly 160 complaints since November 2020. The complaints reported that the “distal end cover” model number MAJ-2315 “dropped out.” The FDA noted although Olympus had performed trending and identified the number of complaints were higher than normal for that type of complaint, “your firm did not consider this increasing trend of complaints to be a quality data input to initiate a corrective and preventive action.”
The FDA had also observed nonconformances for wrinkles observed in the packs of the seal of the distal end cap from Oct. 13 to Oct. 23, 2022. The agency noted the company said the yield control may be appropriate for low-risk nonconformances rather than using its nonconforming product procedure.
“We reviewed your firm’s responses and concluded that they are not adequate,” the FDA stated in the letter.
The agency affirmed it did not agree that the risk to the patient was low enough not to warrant further action. Additionally, regarding wrinkles and air bubble issues in the package seal, these changes resulted in adjustments to manufacturing equipment, which increased the cooling rate of the package after sealing. Although Olympus had performed testing, the agency said the company did not enact revalidation, which needs to be done.
Olympus has reviewed complaints and medical device reports from the past 2 years that correlated with products distributed to the U.S., which was done to determine whether the signals existed to suggest compromised sterility due to the adjustments.
In response, the FDA wrote, “It is not clear whether your firm evaluated devices shipped to other markets as well, that would have the same concern or could possibly be imported into the U.S. by a third party. Your firm should clarify this.”
Although Olympus had completed revalidation on Jan. 31, 2023, and had planned additional correction actions, the FDA stated the company failed to mention a plan to train facility personnel on new procedures. Additionally, Olympus failed to make clear that the retrospective reviews were in line with new requirements.
Again, the agency said Olympus’ responses were “not adequate.”
“Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance,” the FDA stated.
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