FDA 483 - Cambrex Karlskoga AB - May 23, 2026

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.