# FDA 483 - MESI D.O.O. - February 07, 2019

Source: https://www.keypedia.com/records/483/mesi-doo/c1598d14-da94-444d-a3a2-728e4a3002ae

> FDA 483 for MESI D.O.O. on February 07, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MESI D.O.O.
- Inspection Date: 2019-02-07
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of MESI D.O.O., a medical device manufacturer in Ljubljana, Slovenia, from February 4-7, 2019, identified one significant observation. The firm was cited for failing to develop and implement written Medical Device Reporting (MDR) procedures. This indicates a deficiency in their post-market surveillance system.

## Related Officers

- [Investigator at US Food and Drug Administration](https://www.keypedia.com/people/brian-s-keefer/4fec578b-ca72-4d79-8634-3a9fe7ecd9a5)

Company: https://www.keypedia.com/companies/mesi-doo/de59aeb2-8443-4cde-bd13-eb2dbfbb6c20

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