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

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.