# FDA 483 - Unomedical s.r.o. - October 26, 2018

Source: https://www.globalkeysolutions.net/records/483/unomedical-sro/c1fb610a-6a5e-44f7-af07-8288601bdcac

> FDA 483 for Unomedical s.r.o. on October 26, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Unomedical s.r.o.
- Inspection Date: 2018-10-26
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Unomedical s.r.o., a manufacturer in Michalovce, Slovakia, revealed a significant issue regarding their quality system. The firm's procedures for quality audits were found to be inadequately established, specifically lacking detailed requirements for auditing records. This indicates a moderate severity finding related to quality system controls.

## Related Documents

- [WARNING_LETTER - 2014-02-06](https://www.globalkeysolutions.net/records/warning_letter/unomedical-sro/ee55e200-10fd-4315-8b5e-2ed105684e56)
- [483 - 2018-10-26](https://www.globalkeysolutions.net/records/483/unomedical-sro/65b88109-c549-4c70-9b53-51930dd3e5e3)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/john-a-sciacchitano/9f8f49bf-1971-449e-972e-b516418ea78e)

Company: https://www.globalkeysolutions.net/companies/unomedical-sro/9c12336c-c9c1-441d-844b-cbe6671efeaa

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