Mammography Facility Adverse Event and Action Report - May 30, 2019: East Palestine Family Medical Clinic Inc.

On November 20, 2018, the Food and Drug Administration (FDA) initiated an Additional Mammography Review (AMR) of mammograms performed by this facility, conducted by the facility’s accreditation body, the American College of Radiology (ACR), due to deficiencies noted during the October 30, 2018 MQSA Inspection performed by the State of Ohio. On March 19, 2019, the ACR notified the FDA and the facility that the AMR revealed serious deficiencies with clinical image quality and failed to meet the ACR’s clinical image evaluation criteria.

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