FDA files MQSA action against NJ imaging center

The U.S. Food and Drug Administration (FDA) has filed an adverse event and action report against a New Jersey imaging center.

On September 23, the American College of Radiology (ACR) began an additional review of mammograms performed by AP Diagnostic Imaging of Edison, due to serious image quality problems identified during the review of clinical images submitted for the facility's Mammography Quality Standards Act (MQSA) accreditation renewal.

In November, ACR notified AP Diagnostic Imaging that the mammograms it had reviewed did not meet its criteria for clinical image quality and that the deficiencies posed a serious risk to human health. The center did not complete ACR's accreditation renewal process, and its MQSA certificate expired. It is no longer performing mammography.

The FDA required the facility to notify all at-risk patients and referring healthcare providers of the image quality problems found by ACR. The facility completed this notification as of February 24.