# FDA 483 - Cambx Karlskoga AB - March 21, 2014

Source: https://www.keypedia.com/records/483/cambx-karlskoga-ab/d07e60d8-4cad-4a6e-bea6-5fae31c56f13

> FDA 483 for Cambx Karlskoga AB on March 21, 2014. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cambx Karlskoga AB
- Inspection Date: 2014-03-21
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of Cambx Karlskoga AB, an API manufacturer in S Karlskoga, Sweden, identified deficiencies in equipment design, cleaning, sanitation, and maintenance. Specifically, equipment qualification documentation lacked adequate evaluation of operating parameters and failed to establish specifications for equipment reuse and product load limits. These issues indicate a lack of appropriate controls for manufacturing equipment.

## Related Officers

- [Investigator](https://www.keypedia.com/people/meisha-r-waters/4345cca4-40e6-44a2-9cd2-ab17418cd26a)

Company: https://www.keypedia.com/companies/cambx-karlskoga-ab/99168b65-4ca4-4fe5-9cb2-40b7c061158f

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