FDA 483 - Hamamatsu/Queen's PET Imaging Center, LLC - October 11, 2024

Hamamatsu/Queen's PET Imaging Center, LLC, a PET drug manufacturer in Honolulu, HI, was cited for significant deficiencies during an FDA inspection. Observations included inadequate facilities for contamination prevention due to unjustified environmental monitoring action limits and a lack of procedures to differentiate fungal from bacterial CFU. Additionally, the firm failed to adequately qualify vendors for microbiological media and did not conduct thorough investigations or implement effective corrective actions for out-of-calibration equipment affecting multiple batches.