# FDA 483 - Sever Pharma Solutions - December 15, 2017

Source: https://www.keypedia.com/records/483/sever-pharma-solutions/c5c2312b-3df4-4e93-a299-cafcb46ddae5

> FDA 483 for Sever Pharma Solutions on December 15, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sever Pharma Solutions
- Inspection Date: 2017-12-15
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: QPharma AB, a manufacturer in Malmo, Sweden, received a Form FDA 483 with four observations. The firm failed to thoroughly investigate manufacturing discrepancies and lacked adequate control procedures to detect metal particles in drug products. Additionally, electronic records did not meet retention requirements, and the firm could not demonstrate that equipment surfaces contacting in-process materials were pharmaceutical grade.

## Related Officers

- [James Norman](https://www.keypedia.com/people/james-norman/2e917a36-505a-44ed-b4e3-3dc0ef90a1f0)
- [Damon Brown](https://www.keypedia.com/people/damon-brown/a2020e98-4078-43bc-b2c9-6a7fd5155a2a)

Company: https://www.keypedia.com/companies/sever-pharma-solutions/d4aaa41d-8c80-4520-bc82-45ae10cb4795

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321