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QT Imaging passes first FDA inspection with no violations

Tue, 07 Jul 2026 08:30:58 -0400

QT Imaging Holdings, Inc. (Nasdaq: QTI) announced the completion of its first routine inspection by the U.S. Food and Drug Administration with zero Form 483 observations issued.

The FDA inspection reviewed QT Imaging's Quality Management System and related operational processes. The agency's investigator issued no Form 483 observations and provided positive feedback regarding the organization of the company's quality management system and its responsiveness during the inspection.

A Form 483 is issued at the conclusion of an FDA inspection when an investigator has observed conditions that may constitute violations of the Food, Drug and Cosmetic Act and related regulations.

"The successful completion of

QT Imaging passes first FDA inspection with no violations

Tue, 07 Jul 2026 08:30:58 -0400

QT Imaging Holdings, Inc. (Nasdaq: QTI) announced the completion of its first routine inspection by the U.S. Food and Drug Administration with zero Form 483 observations issued.

A Form 483 is issued at the conclusion of an FDA inspection when an investigator has observed conditions that may constitute violations of the Food, Drug and Cosmetic Act and related regulations.

"The successful completion of

QT Imaging Announces Successful Completion of First FDA Routine Inspection with Zero Form 483 Observations

Tue, 07 Jul 2026 08:30:00 -0400

FDA inspection outcome highlights the Company's robust Quality Management System, operational discipline, and commitment to the highest standards of quality

NOVATO, Calif.--(BUSINESS WIRE)-- QT Imaging Holdings, Inc. (Nasdaq: QTI) (“QT Imaging” or the “Company”), a medical device company engaged in the research, development, and commercialization of innovative body imaging systems, announces the successful completion of 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

QT Imaging Announces Successful Completion of First FDA Routine Inspection with Zero Form 483 Observations

Tue, 07 Jul 2026 08:30:00 -0400

FDA inspection outcome highlights the Company's robust Quality Management System, operational discipline, and commitment to the highest standards of quality

The FDA inspection reviewed QT Imaging’s Quality Management System (QMS) and related processes that support the Company’s operations, with no Form 483

QT Imaging Announces Successful Completion of First FDA Routine Inspection with Zero Form 483 Observations

Tue, 07 Jul 2026 08:30:00 -0400

FDA inspection outcome highlights the Company's robust Quality Management System, operational discipline, and commitment to the highest standards of quality

The FDA inspection reviewed QT Imaging’s Quality Management System (QMS) and related processes that support the Company’s operations, with no Form 483

QT Imaging Announces Successful Completion of First FDA Routine Inspection with Zero Form 483 Observations

Tue, 07 Jul 2026 08:30:00 -0400

FDA inspection outcome highlights the Company's robust Quality Management System, operational discipline, and commitment to the highest standards of quality

The FDA inspection reviewed QT Imaging’s Quality Management System (QMS) and related processes that support the Company’s operations, with no Form 483

QT Imaging Announces Successful Completion of First FDA Routine Inspection with Zero Form 483 Observations

Tue, 07 Jul 2026 08:30:00 -0400

FDA inspection outcome highlights the Company's robust Quality Management System, operational discipline, and commitment to the highest standards of quality

The FDA inspection reviewed QT Imaging’s Quality Management System (QMS) and related processes that support the Company’s operations, with no Form 483

QT Imaging Announces Successful Completion of First FDA Routine Inspection with Zero Form 483 Observations

Tue, 07 Jul 2026 08:30:00 -0400

FDA inspection outcome highlights the Company's robust Quality Management System, operational discipline, and commitment to the highest standards of quality

The FDA inspection reviewed QT Imaging’s Quality Management System (QMS) and related processes that support the Company’s operations, with no Form 483

QT Imaging Announces Successful Completion of First FDA Routine Inspection with Zero Form 483 Observations

Tue, 07 Jul 2026 08:30:00 -0400

FDA inspection outcome highlights the Company's robust Quality Management System, operational discipline, and commitment to the highest standards of quality

The FDA inspection reviewed QT Imaging’s Quality Management System (QMS) and related processes that support the Company’s operations, with no Form 483

QT Imaging Announces Successful Completion of First FDA Routine Inspection with Zero Form 483 Observations

Tue, 07 Jul 2026 08:30:00 -0400

FDA inspection outcome highlights the Company's robust Quality Management System, operational discipline, and commitment to the highest standards of quality

The FDA inspection reviewed QT Imaging’s Quality Management System (QMS) and related processes that support the Company’s operations, with no Form 483

Form DEF 14A QT IMAGING HOLDINGS, For: Jul 02

Thu, 02 Jul 2026 08:01:00 -0400

si-local-file:///var/storage/secattach/20260702/26724218.html

Form DEF 14A QT IMAGING HOLDINGS, For: Jul 02

Thu, 02 Jul 2026 08:01:00 -0400

si-local-file:///var/storage/secattach/20260702/26724218.html

QT Imaging’s CEO Presents Sports Shiftmaker Award to Tennis Champion and Breast Cancer Survivor Martina Navratilova During Wimbledon Week

Mon, 29 Jun 2026 09:28:00 -0400