Everyway Medical Instruments Co., Inc.May 13, 2019

FDA 483 - Everyway Medical Instruments Co., Inc. - May 13, 2019

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Record Details

This FDA Form 483 was issued to Everyway Medical Instruments Co., ltd. following an inspection of their device manufacturing facility in New Taipei City, Taiwan. The inspection revealed deficiencies in design validation, specifically regarding clinical investigation records for an incontinence device. Additionally, conflicting information was found regarding the cleaning validation and instructions for use for a vaginal incontinence probe.

Company: Everyway Medical Instruments Co., Inc.
Inspection Date: May 13, 2019
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Stephen D. Eich (investigator)

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ID · ffcdb275-8f73-4c7e-b3eb-63c689a3b766