A chain of Baltimore radiology centers and its owner are in default on a $1.16 million fine from the FDA for performing mammograms after one of its facilities lost its certification due to equipment problems, which is considered a violation of the Mammography Quality Standards Act of 1992, according to an FDA document sent June 20.
The FDA issued the notice of default to Amile A. Korangy, MD, owner of Korangy Radiology Associates (KRA), after the FDA said that he failed to make a scheduled payment of $579,000 by June 12.
The letter stated that an FDA attorney rejected Korangy’s last minute offer on June 12 to pay $150,000, followed by payments of $100,000 per month until the debt was paid.
In fact, the notice stated that “the entire $1.158 million owed by you, plus interest, is now immediately due and payable.” Based on the agency’s initial agreement with Korangy, the FDA said the “interest on any unpaid amount shall accrue at the rate of 7.5 percent per annum compounded daily from the date of default on the full remaining unpaid balance.”
“If I have the money, I'll pay it,” Korangy told the Baltimore Sun. “If I don't have the money, I cannot pay it.” He also said that he is still appealing the penalty.
The FDA sought civil penalties against Korangy after finding that his Catonsville, Md., radiology center had performed 192 mammograms over a two-month period in 2002 after it lost the certification required under federal law, the Sun reported.
The American College of Radiology (ACR) determined in early 2002 that mammography equipment at Korangy's Catonsville facility produced poor-quality images and failed to meet standards for certification, the Sun said. The group subsequently informed Korangy of its finding by letter. Korangy purchased and began using new equipment.
The FDA complaint said that he continued to perform mammograms without certification until late July, when the new equipment was approved for use.
Korangy appealed the original FDA ruling to an administrative law judge, stating that he could not afford the penalty, according to the Sun. He also argued in legal documents that the fine was excessive, and that he never received FDA letters indicating he was in violation of federal law.
The Sun reported that the judge rejected those arguments, noting among other things that Korangy had been “less than forthcoming” in providing financial information proving he lacked the ability to pay the fine.
KRA’s centers operate under the name Baltimore Imaging Centers, which has nine locations.