# FDA 483 - Cambrex Karlskoga AB - May 23, 2026

Source: https://www.keypedia.com/records/483/cambrex-karlskoga-ab/fd80de6f-7a23-4fe8-a03f-2f8f4d6270f4

> FDA 483 for Cambrex Karlskoga AB on May 23, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cambrex Karlskoga AB
- Inspection Date: 2026-05-23
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Cambrex Karlskoga AB, an API manufacturer in Karlskoga, Sweden, was inspected by the FDA. The inspection revealed significant deficiencies in the firm's complaint handling system, specifically regarding the timely closure of customer complaints. The firm failed to close 80% of reviewed complaints within its own SOP's specified timeframe and lacked a formal process for justifying extensions.

## Related Officers

- [Nicholas L. Paulin](https://www.keypedia.com/people/nicholas-l-paulin/a8e0649a-614f-499b-8fdc-1217f7d71887)

Company: https://www.keypedia.com/companies/cambrex-karlskoga-ab/c3f2350f-a38e-4e0c-9bac-e94c0255764c

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8