# FDA 483 - ScandiDos AB - July 12, 2018

Source: https://www.globalkeysolutions.net/records/483/scandidos-ab/ec7a2278-389b-420b-81c0-a462244a9766

> FDA 483 for ScandiDos AB on July 12, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ScandiDos AB
- Inspection Date: 2018-07-12
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of ScandiDos AB, a medical device manufacturer in Uppsala, Sweden, revealed significant deficiencies in their quality management system. The firm was cited for inadequate procedures related to design transfer, control of non-conforming products, and documentation of incoming product acceptance. Additionally, Device History Records were found to be incomplete, lacking critical information.

## Related Documents

- [483 - 2018-07-09](https://www.globalkeysolutions.net/records/483/scandidos-ab/1cdc7448-f5a1-4c03-a7c4-0ed0b5d5f4ac)

## Related Officers

- [Christopher B. May](https://www.globalkeysolutions.net/people/christopher-b-may/b2173a59-d37b-41f1-aa39-eefd854722b8)

Company: https://www.globalkeysolutions.net/companies/scandidos-ab/8a121d76-151b-4e72-b3da-c6415ebaf094

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