FDA Flags Validation, Complaint Handling, DHR Issues at Japanese Facility

January 26, 2018

An FDA inspection at a medical device facility in Akita, Japan revealed nonconformities in process and software validation, as well as complaint handling and device history records.

The investigator who visited the Tanita Corporation of Akita facility last June found at least two processes had not been validated, one of which involved final device assembly. Another process lacked protocols for ensuring that it was validated with “a high degree of assurance” and “capable of producing consistent results,” the investigator wrote in a Form 483.

In addition, the firm failed to provide any evidence of validating the intended use of the software it had been using for documenting and updating nonconformities, data analysis, supplier management, and training records. The software had not been validated to ensure it “can prevent unauthorized changes from being made to the data,” the investigator said.

Customer complaint handling was also an issue. The reviewed complaints had not been processed in a timely manner, or evaluated to determine whether the events described should have been reported to the FDA.

For example, out of two complaint investigations that had been initiated in August 2014, one was not closed until May 2017 while the other had yet to be closed at the time of the FDA visit.

Several of the firm’s devices in the U.S. had been replaced due to reasons such as “Failed load cell,” “No calibration,” and “Failed SW Membrane” — all of which “represent possible complaints, but were not reviewed, evaluated or investigated by the firm,” the investigator said.

The facility’s device history records were found to be incomplete, missing required information such as primary identification labeling for each production unit and rework activities.

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