Cambridge Isotope Laboratories, Inc. – FDA 483, Mar 25, 2016

Cambridge Isotope Laboratories, Inc. in Andover, MA, an API manufacturer, was cited for significant deficiencies in its quality unit's oversight and investigation processes, as well as inadequate control over critical manufacturing equipment and processes for C-13 UREA API. The inspection revealed issues with non-conformance investigations, change control management, purification column quality assurance, and maintenance programs for critical valves and cylinders. These observations indicate a need for improved quality system controls to ensure product safety and quality.