483
Cambrex Karlskoga ABFDA 483 - Cambrex Karlskoga AB - May 23, 2016
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
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.
Open in Dashboard
ID · fd80de6f-7a23-4fe8-a03f-2f8f4d6270f4