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.
In a statement shared with MassDevice, Olympus said it took the warning letter very seriously. “Olympus is developing a comprehensive response to the warning .etter, which will be provided to FDA within the required timeframe. As noted in the 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.”
FDA says Olympus failed to implement corrective and preventive action
This violation includes a range of quality problems, such as analyzing processes, work operations, and concessions. It also includes quality audit reports, quality records, service records, complaints
FDA said that, since November 2020, Olympus Medical received approximately 160 complaints. These complaints described the “distal end cover” model (#MAJ-2315) as “dropped out.” The agency said Olympus performed trending and identified the number of complaints came in above the expected total for that type of complaint. However, FDA says, Olympus did not consider this increasing trend to be a quality data input to initiate a corrective and preventive action.
The agency also observed non-conformances for observed wrinkles in the package seal of the distal end cap between Oct. 13 and Oct. 23, 2022. It said Olympus stated that yield control may be appropriate for some low-risk nonconformances. The company did this instead of using its nonconforming product procedure.
FDA said it reviewed Olympus’ responses and concluded they are not adequate. The agency does not agree that risk to patients is low enough to not warrant further action.
Review and evaluation process failure
The FDA said the wrinkles and air bubble issue in the package seal of a sterile product resulted in a modification to manufacturing equipment. This modification increased the cooling rate of the package after sealing. While Olympus performed some testing, FDA said, it enacted no re-validation, which must be done.
Additionally, the FDA said Olympus reviewed complaints and medical device reports (MDRs) from the last two years associated with all products distributed to the U.S. The company did this to determine if signals existed to suggest compromised sterility due to the modification.
“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 US by a third party,” FDA wrote. “Your firm should clarify this.”
While Olympus completed revalidation on Jan. 31, 2023, and had additional corrective actions planned, FDA said it failed to mention a plan to train personnel on the new procedures. The agency also said Olympus failed to clarify that the retrospective reviews fell in line with new requirements.
Again, FDA labeled Olympus’ responses as “not adequate.”
Required review by a formally designated unit
The FDA referenced a complaint received by Olympus on Nov. 21, 2020. It described that “a patient sustained esophageal trauma.” The complaint also said “tissue from the esophagus was caught up in the distal tip of the device.” Additionally, the complaint stated that the “customer attributes these events to cracked caps.” The customer noticed a “few already cracked when coming out of the packaging.”
According to the FDA, procedure requires investigations for these complaints within 30 days. The agency said Olympus failed to investigate the complaint until 2022. Olympus found 98 complaints not initiated according to procedure during its retrospective review. FDA said Olympus stated its intent to conduct necessary investigations and submit MDRs by Feb. 28, 2023.
“We reviewed your firm’s responses and concluded that they are not adequate,” FDA said.
