FDA 483 - Pharmalogic Puerto Rico Inc - December 27, 2013

An FDA inspection of Lantheus MI Radiopharmaceuticals Inc. in San Juan, PR, a PET Manufacturer, revealed significant deficiencies in quality control and aseptic processing. The firm failed to conduct investigations into environmental excursions, lacked adequate procedures for incoming material control, and exhibited poor production and process controls, including issues with operator qualification and aseptic technique. Additionally, quality assurance procedures for reviewing cleaning records were not consistently followed.