FDA 483 - Cambridge Isotope Laboratories, Inc. - December 09, 2020

An FDA inspection of Cambridge Isotope Laboratories, Inc. in Tewksbury, MA, a PET Manufacturer, revealed significant deficiencies in their manufacturing processes for 18O Water. Observations included inadequate investigations into container closure system failures, lack of proper specifications for drug product containers, and insufficient production and process controls. The firm also failed to ensure packaging materials were suitable for their intended use through proper sampling and testing.