# FDA 483 - Euro Diagnostica AB - January 19, 2017

Source: https://www.keypedia.com/records/483/euro-diagnostica-ab/67be2b88-1daa-46b9-9af8-a9c764fdd2f4

> FDA 483 for Euro Diagnostica AB on January 19, 2017. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Euro Diagnostica AB
- Inspection Date: 2017-01-19
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Euro Diagnostica AB in Malmo, Sweden, was inspected by the FDA from January 16-19, 2017. The inspection revealed significant deficiencies in the firm's quality system, including inadequate procedures for medical device reporting, complaint handling, design control, corrective and preventive actions, and internal quality audits. These issues indicate a lack of robust quality management practices for a medical device manufacturer.

## Related Documents

- [WARNING_LETTER - 2017-01-19](https://www.keypedia.com/records/warning_letter/euro-diagnostica-ab/97b48702-50cb-453c-a7ce-6c8b00d75341)

## Related Officers

- [Dedicated Device Cadre](https://www.keypedia.com/people/dedicated-device-cadre/693932db-dd86-453f-9b51-a63444b07281)
- [Consumer Safety Officer](https://www.keypedia.com/people/catherine-j-laufmann/920b7656-2847-408d-ba15-3989283d8c94)

Company: https://www.keypedia.com/companies/euro-diagnostica-ab/7d939a93-9dfc-4058-b2bd-f4769c279603

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