The U.S. Food and Drug Administration (FDA) has sent a warning letter to MRI Imaging Specialist in Norcross, GA, for what the agency called continued violations of the Mammography Quality Standards Act (MQSA).
In a follow-up inspection of the facility on February 19, an FDA representative found one level 1 violation and seven level 2 violations, according to the warning letter. In addition, the practice failed to respond to the MQSA facility inspection report.
The follow-up inspection was performed after two previous noncompliant MQSA inspections on July 1, 2014, and June 17, 2015. The FDA gave MRI Imaging Specialist 15 working days to respond to the March 16 letter and provide the specific steps it has taken or will take to correct and prevent the recurrence of the violations named in the letter and similar violations, including projected time frames. MRI Imaging Specialist will also need to provide sample records that demonstrate proper record-keeping procedures, the FDA said.
