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

Source: https://www.keypedia.com/records/483/mego-afek-ac-ltd/93608a68-13fd-45e3-adcd-dc94d9ba54ae

> FDA 483 for Mego Afek AC Ltd. on February 06, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mego Afek AC Ltd.
- Inspection Date: 2020-02-06
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Officers

- [Investigator](https://www.keypedia.com/people/vicky-l-cruz/282da571-56be-48f4-96c6-d590829b12c2)

Company: https://www.keypedia.com/companies/mego-afek-ac-ltd/e091b05f-d7c3-4c05-b0ce-7a1848ed72fc

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd