FDA 483 - Cambx Karlskoga AB - March 21, 2014

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.