FDAnews Device Daily Bulletin
Medical Devices / Inspections and Audits

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

Jan. 30, 2018
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An FDA inspection at a medical device facility in Akita, Japan revealed nonconformities with 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.

In addition, the firm failed to provide any evidence of validating the software it had been using for documenting and updating nonconformities, data analysis, supplier management, and training records.

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