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

During an inspection from October 8-11, 2024, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Hamamatsu/Queen's PET Imaging Center, LLC, a PET drug manufacturer. The inspection identified several critical issues requiring prompt corrective action. Key observations included inadequate facilities and equipment controls, specifically regarding environmental monitoring. The firm's action limits for bacterial contamination in its ISO 5 cleanroom lacked scientific justification, potentially allowing uninvestigated excursions, and there were no procedures to differentiate between fungal and bacterial growth. Furthermore, laboratory controls were deficient, as the company failed to adequately qualify vendors for microbiological media used in critical environmental and personnel monitoring, compromising sterility assurance. Lastly, the quality system exhibited weaknesses in managing non-conformances. An investigation into an out-of-calibration pressure gauge, used for filter integrity testing across multiple production batches, was deemed insufficient, lacking a thorough risk assessment and effective corrective and preventive actions. These findings indicate significant concerns in contamination control, material quality oversight, and investigation processes, necessitating a comprehensive response from the company.