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 4, 2007
ADVERSE DETERMINATION LETTER
BY FACSIMILE &
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Mr. John F. McGuire
President and CEO &
Executive Vice President
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. McGuire:
Paragraph IV.B.17.a. of the amended Consent Decree of Permanent Injunction
(Decree) dated April 15, 2003, requires that the American National Red
Cross (ARC) must ensure that its regional blood service facilities (regions)
notify the Food and Drug Administration (FDA) “in writing within
5 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.” Ensuring
traceability of blood and blood components is critical to protect public
health. For example, 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.
For the period September 1, 2005, through December 31, 2006, ARC reported
to FDA that it failed to locate 200 blood or blood component items within
72 hours of initially learning that they were not in their assigned locations. 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 $650 for each of 53 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. See Attachment 1 (List
of Lost Products -- Penalty Assessed).
Attachment 2 is a list of 147 instances reported by ARC, but excluded
from penalty assessment by FDA at this time. According to ARC’s
reports, thirty six of these instances involved either: the amount of
blood collected was insufficient; no blood was collected from the donor;
or the container was broken or leaking, none of which could be further
processed. Because such problems prevent any blood collected from being processed and distributed, they would be expected to present
a low risk to public health. For that reason, we are not assessing
a fine for these instances this time. Nevertheless, these occurrences
reflect problems in the blood inventory management system that should
be prevented. FDA reminds ARC that it must maintain a record of
the disposition of such instances in accordance with FDA regulations and
that it should strengthen its efforts to reduce their occurrence.
Additionally, FDA is exercising its regulatory discretion in not assessing
a penalty for each of the 111 lost blood products listed in the June 21,
2006 report for the Lewis and Clark Region. ARC reported that all
of these products were part of one incident involving biohazardous waste
disposal on that day. Although ARC failed to follow certain of its
own standard operating procedures in documenting and verifying boxes of
material picked up, the disposal control records show that ARC properly
designated the units for disposal. We therefore believe this incident
involved a low risk to public health and will not assess a fine on this
occasion, without restricting our ability to assess a fine in the future
for similar failures to follow standard operating procedures.
Paragraph IV.B.17.a. further states that “[w]ithin 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
five reports (covering seven products) 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. In the exercise of its enforcement discretion and without
committing to whether or not similar future events will result in fines,
FDA is not assessing a penalty for two of these late reports, which
were four and seven days late. However, FDA is assessing
a penalty of $500 for one report that was 24 days late and $10,000 for
each of two reports that were 676 days and 206 days late. See
Attachment 3.
The total fine that FDA is imposing is $54,950. 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., MPH, Director, Center for Biologics
Evaluation and Research, 1401 Rockville Pike, Suite 200 N, Rockville,
Maryland 20852.
Sincerely yours,
[Handwritten Signature]
Evelyn
Bonnin
Director,
Baltimore District
Attachments |