DEPARTMENT OF HEALTH AND HUMAN SERVICES
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Office of the General Counsel
Office of the Chief Counsel
Food and Drug Administration
5600 Fishers Lane, GCF-1
Rockville, MD 20857
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June 20, 2008
NOTICE OF DEFAULT
VIA FIRST CLASS &
CERTIFIED MAIL
AND FACSIMILE TO 410-788-2843
Amile A. Korangy, M.D.
Korangy Radiology Associates, P.A. d/b/a Baltimore Imaging Centers
724 Maiden Choice Lane, Suite 102
Catonsville, MD 21228
Dear Dr. Korangy,
On March 10, 2008, after extremely protracted negotiations, you entered
into the attached
agreement (Agreement) with the United States Food and Drug Administration (FDA)
on behalf
of yourself and your company, Korangy Radiology Associates, P.A. (KRA). The
Agreement was
executed on FDA's behalfby Daniel Schultz, M.D., Director, Center for Devices
and
Radiological Health (CDRH), on March 14, 2008.
Pursuant to the Agreement, you and KRA are jointly and severally liable
for the full $1.158 million civil money penalty assessed against you both for
your violations of the Mammography
Quality Standards Act of 1992, 42 U.S.C. § 263b. Agreement, ¶ D.
You and KRA agreed to pay
FDA the sum of $579,000 within 90 days from the date ofthe Agreement's execution.
Agreement, ¶ C. Because the Agreement was fully executed on March 14,
2008, your first
payment of $579,000 was due to FDA on June 12,2008.
On June 9,2008, your lawyer Timothy Lynch contacted Marci Norton, an attorney
on my staff, to
notify her that you would not make the payment as you had agreed and to suggest
a revised
payment plan in which you would pay $150,000 on June 12, 2008, and $100,000
a month until
the initial $579,000 was paid in full. On June 10, 2008, Ms. Norton e-mailed
Mr. Lynch that any
change in the terms of the Payment Agreement was unacceptable to FDA. Ms. Norton
told Mr. Lynch via e-mail on June 11, 2008, that FDA's position was final.
The Agreement provides that if you or KRA fail to make any ofthe agreed
upon payments, FDA
may send you a notice declaring you to be in default, at which time the full
remaining unpaid
balance shall become immediately due and payable without demand, process, notice,
or other
fonnality, judicial or otherwise, of any kind, all of which you expressly waived.
Agreement, ¶ D.
The Agreement further provides, "interest on any unpaid amount shall
accrue at the rate of 7.5%
per annum compounded daily from the date of default on the full remaining unpaid
balance." Id.
This letter serves as FDA's notice of your default. The
entire $1.158 million owed by you. plus
interest. is now immediately due and payable. Please remit a certified check
and/or money order
made payable to the "United States Treasury," and sent via express
mail to: Nikol Echols, 5600
Fishers Lane, HFA-121, Room 11-64, Rockville, Maryland 20857, and include with
your
payment a copy of this letter and the Judgment issued by the Court ofAppeals
for the Fourth
Circuit on August 17, 2007. Please be advised that FDA is referring this matter
to appropriate
authorities to ensure enforcement of the agreement and collection ofthe entire
amount, plus all
interest due upon collection.
Sincerely yours,
[Handwritten Signature]
Eric M. Blumberg
Deputy Chief Counsel for Litigation
United States Food and Drug Administration
ATTACHMENT
cc: Timothy Lynch, Esq. (via Fed Ex, facsimile,
and e-mail)
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