FDA 483 - Johns Hopkins University PET Center - September 02, 2016

Johns Hopkins University PET Center in Baltimore, MD, a PET drug manufacturer, was cited for significant deficiencies during an FDA inspection. Observations included inadequate master production records with component lot number discrepancies, failure to ensure reliable suppliers for media, and a lack of proper procedures for equipment calibration and temperature monitoring in incubators, leading to temperature excursions. These issues indicate a need for improved quality control and record-keeping practices.