QT Imaging completes first FDA routine inspection

QT Imaging announced the successful completion of its first routine inspection by the FDA, with zero Form 483 observations. The FDA inspection reviewed QT Imaging's Quality Management System and related processes that support the company's operations, with no Form 483 observations issued. The inspector also provided positive feedback regarding the organization of QT Imaging's QMS and the company's responsiveness throughout the inspection process. An FDA Form 483 is issued at the conclusion of an inspection when an FDA investigator has observed conditions that may constitute violations of the Food, Drug and Cosmetic Act and related regulations.