CML-Europe Completes First FDA Inspection

Cambridge Major Laboratories Europe, B.V. has successfully completed its first FDA inspection at its Weert facility that included a pre-approval inspection and general quality systems audit, which concluded with no Form 483 being issued. CML-Europe supplies development services and niche commercial API’s to a growing customer base.
 
“This successful FDA inspection represents a major milestone for the CML-Europe facility,” said Peter van Tilburg, president of CML-Europe. “We place Quality above all else, and I am so proud that the dedication and performance of the CML-Europe team resulted in this successful outcome. CML-Europe will always be committed to quality and strong leadership, and this commitment is evidenced by two significant recent hires.”
 
Dr. Marcel Schreuder Goedheijt has been appointed director of operations, and Mr. Jan Douwstra as head of production. Dr. Goedheijt brings extensive chemical pharmaceutical and business experience from his previous positions at DSM, DSM Pharma Chemicals, MSD and Diosynth BV. Mr. Douwstra held previous positions at the Academic Medical Centre, Amsterdam and St. Radboud University Medical Centre, Nijmegen, as well as Abbott Healthcare B.V., Solvay Pharmaceuticals B.V. Weesp, and Smit & Zoon B.V. Amersfoort.