# FDA 483 - Medi-Globe s.r.o. - May 24, 2018

Source: https://www.globalkeysolutions.net/records/483/medi-globe-sro/b92bd626-23ed-47d5-863b-52ee8660fd2f

> FDA 483 for Medi-Globe s.r.o. on May 24, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medi-Globe s.r.o.
- Inspection Date: 2018-05-24
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Med-Globe s.r.o., a medical device manufacturer in Hranice, Czech Republic, identified three observations related to deficiencies in their quality system. The firm was cited for inadequate procedures concerning corrective and preventive actions, quality audits, and calibration. These findings indicate a need for the firm to strengthen its procedural controls to ensure compliance and product quality.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/medi-globe-sro/933c5ac6-eb42-4ad3-8e19-3b9109a25d1f

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