The FDA issued Olympus a warning letter regarding adultered devices following an inspection of the company’s Tokyo facility.
This marks the latest warning letter sent by the FDA to Olympus. The company received two separate letters at the end of last year.
According to the letter, the agency conducted an inspection of the Tokyo facility between Nov. 7, 2022, and Nov. 10, 2022. Olympus makes endoscopes and endoscope accessories at the Tokyo plant. These include single-use distal covers for duodenoscopes and single-use suction valve accessories for bronchoscopes.
FDA said the inspection revealed that these devices “are adulterated.” This means that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation.
The agency said it received responses from Seiji Morishita, Olympus director, dated Dec. 5, 2022, Jan. 10, 2023 and Feb. 13, 2023.
In the letter, the FDA alleges violations, including failure to adequately establish and maintain procedures for implementing corrective and preventive action. It also says Olympus failed to ensure that, when changes or process deviations occur, it reviews and evaluates the process and performs revalidation where appropriate. Finally, the FDA said Olympus failed to adequately establish and maintain procedures for receiving, reviewing and evaluating complaints by a formally designated unit.
