FDA 483 - Johns Hopkins University PET Center - April 19, 2024

An FDA inspection of Johns Hopkins University PET Center in Baltimore, MD, a PET drug manufacturer, revealed significant deficiencies in quality control. Observations included inadequate environmental monitoring for sterile drug production, lack of procedures for component examination and approval, and insufficient cleaning procedures and documentation for equipment. These issues raise concerns about the quality and purity of their sterile injectable radioactive drug products.