DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Baltimore District Office
Central Region
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5454
FAX: (410) 779-5707
April 2, 2004
ADVERSE DETERMINATION LETTER
BY FACSIMILE &
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Mr. Alan McCurry
Executive Vice President and CEO
Biomedical Services
American National Red Cross
2025 E Street, N.W.
Washington, D.C. 20006
RE: United States v. American National Red Cross, Civil Action No.
93-0949 (JGP)
Dear Mr. McCurry:
Paragraph IV.B.17.a. of the amended Consent Decree of Permanent Injunction
(Decree) dated April 15, 2003, requires that within 30 days of entry
of the Decree, the American National Red Cross (ARC) must modify its
standard operating procedure to ensure that its regional blood service
facilities (regions) notify the Food and Drug Administration (FDA) “in
writing within five business days after a region has failed to locate
any blood or blood component within 72 hours of the time that the region
initially learned that such blood or blood component was not in its
assigned location.” For the period May 15, 2003, through December
31, 2003, ARC reported to FDA that it failed to locate 47 units of
blood or blood components within 72 hours of initially learning that
such blood products were not in their assigned locations. (See Attachment
1, PDF [26
KB])
Ensuring traceability of blood and blood components is critical to
protecting public health. Any unit of blood or blood component, even
one initially deemed suitable for distribution, could become subject
to retrieval or lookback based on subsequent information regarding
donor suitability or infectious disease test results for subsequent
donations from the same donor. ARC’s failure to maintain traceability
for 47 units of blood or blood components during the period May 15,
2003, through December 31, 2003, reflects a failure to maintain adequate
inventory control.
Paragraph IV. B. 17.a. of the Decree states that “FDA may assess
a penalty of up to $1,000 for each unit of blood and each blood component
that ARC fails to locate within 72 hours after a region initially learned
that such blood or blood component was not in its assigned location.” In
this instance, FDA is assessing a penalty of $750 for each of the 47
units of blood or blood components that ARC failed to locate within
72 hours after a region learned that the blood or blood component was
not in its assigned location. Those lost products are listed in Attachment
1, PDF [26
KB].
Additionally, Paragraph IV.B.17.a. states that “within 5 business
days thereafter, ARC shall notify FDA in writing of each such lost
unit of blood or blood component and if such timely notification is
not made, FDA may assess a penalty of up to $10,000 for each such notification
failure.” FDA identified two ARC reports that were not submitted
to FDA within five business days of the day that ARC initially learned
that the blood or blood components were not in their assigned locations.
Those late reports were from one region and were substantially late,
specifically, 14 and 82 days. (See Attachment
2, PDF [11
KB]) In this instance,
FDA is assessing a penalty of $10,000 for the report that was 82 days
late and $5,000 for the report that was 14 days late.
The total fine that FDA is imposing is $50,250. As provided in Paragraph
IX of the Decree, if ARC agrees with this adverse determination, it
must within 20 days of receipt of this letter, notify FDA of its agreement
and its intent to pay the fine. If ARC disagrees with FDA’s adverse
determination, it must respond in writing within 20 days of receipt
of this letter, explaining its reasons for disagreeing with FDA’s
determination. Your response must be submitted to me at the Food and
Drug Administration, Baltimore District Office, 6000 Metro Drive, Suite
101, Baltimore, Maryland 21215, with a copy to Jesse Goodman, M.D.,
Director, Center for Biologics Evaluation and Research, 1401 Rockville
Pike, Suite 200 N, Rockville, Maryland 20852.
Sincerely yours,
(signed) Lee Bowers
Lee Bowers
Director, Baltimore District
ATTACHMENTS
cc: Marsha Johnson Evans
President & CEO
American National Red Cross
2025 E Street, N.W.
Washington, D.C. 20006
Mary Elcano
General Counsel
American National Red Cross
2025 E Street, N.W.
Washington, D.C. 20006
David T. McLaughlin
Chairman, Board of Governors
American National Red Cross
2025 E Street, N.W.
Washington, D.C. 20006
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