News | Breast Imaging | July 07, 2026
QT Imaging Successfully Completes First FDA Inspection with Zero Observations
FDA inspection outcome had zero Form 483 observations. This highlights the company’s Quality Management System, operational discipline, and commitment to quality
July 7, 2026 — QT Imaging Holdings, Inc. recently announced it has successfully completed its first routine inspection by the U.S. Food and Drug Administration (FDA), with zero Form 483 observations
The FDA inspection reviewed QT Imaging’s Quality Management System (QMS) 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
“The successful completion of our first FDA routine inspection with zero Form 483 observations is a significant operational achievement and a strong validation of the quality systems and processes we have established at QT Imaging,” said Steve Choate, Chief Operating Officer of QT Imaging. “This outcome reflects the dedication of our team, the maturity of our Quality Management System, and our commitment to operational excellence. As we continue to scale manufacturing, expand commercialization globally, and support a growing customer base, maintaining the highest standards of quality and regulatory compliance will remain at the core of everything we do.”
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. The absence of a Form 483 following the company’s first FDA routine inspection represents an important operational milestone for the company
