Mego Afek AC Ltd.February 6, 2020

FDA 483 - Mego Afek AC Ltd. - February 06, 2020

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Record Details

Mego Afek AC Ltd. in Afek, Israel, a medical device manufacturer, was inspected by the FDA from February 3-6, 2020. The inspection revealed that procedures for finished device acceptance were not adequately established, leading to a medical device being released for distribution before all manufacturing and testing activities were completed. This indicates a failure to follow established quality procedures.

Company: Mego Afek AC Ltd.
Inspection Date: February 6, 2020
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Vicky L. Cruz (Investigator)

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ID · 93608a68-13fd-45e3-adcd-dc94d9ba54ae