FDA files action against Nev. imaging center for mammography

The U.S. Food and Drug Administration (FDA) has issued an adverse event warning for a Nevada imaging facility, Osteopathic Medical Assoc. of Las Vegas.

On June 14, the American College of Radiology (ACR) conducted a review of mammograms performed at the facility due to deficiencies found during an annual Mammography Quality Standards Act (MQSA) inspection performed by the state of Nevada. In August, the ACR notified the facility that three out of six mammography cases failed to meet the college's clinical image quality criteria and revoked its accreditation. Also in August, the FDA declared the center's MQSA certificate no longer in effect.

The FDA required Osteopathic Medical Assoc. to notify its patients and their providers of the mammography quality problems. It has done so but is still not currently performing mammography, the FDA said.