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
July 13, 2004
CONSENT DECREE CORRESPONDENCE
BY FACSIMILE &
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Mr. John F. McGuire
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:
FDA has reviewed the American National Red Cross’ (ARC) submission
that was received by the Food and Drug Administration’s (FDA)
Baltimore District Office on June 22, 2004. That submission includes
ARC’s third revisions to the Problem Management standard operating
procedure (SOP) and associated procedures. Following its review
of ARC’s Problem Management SOP and associated procedures
submitted on April 30, 2004, and the modification submitted on May
5, 2004, FDA issued a letter dated June 2, 2004, directing ARC to
make specific changes to the SOP, requesting additional information,
and providing comments. ARC’s June 22, 2004 submission is
its response to that letter. Under Paragraph IV.B.1. of the Amended
Consent Decree of Permanent Injunction (Decree), entered on April
15, 2003, ARC is required to establish and submit to FDA the Problem
Management SOP. Once FDA notifies ARC that it appears adequate,
ARC must implement the SOP.
During its review of the June 22, 2004 submission, FDA identified
several concerns and raised those with ARC by telephone on July
1, 2004. In response, ARC modified two work instructions in the
SOP and sent evidence of those modifications to the FDA Baltimore
District office by electronic mail on July 7, 2004. Based on its
review of the above-mentioned submissions, FDA finds that, contingent
upon incorporation of the May 5, 2004, June 22, 2004, and July 7,
2004 modifications into the April 30, 2004 version, the Problem
Management SOP appears adequate.
ARC has 90 days from receipt of this letter to implement the SOP.
FDA will verify adequacy of the SOP and its implementation during
future inspections of ARC facilities.
Mr. John F. McGuire
Page 2
If you have any questions regarding this letter, please contact
me at (410) 779-5424.
Sincerely yours,
(signed) Lee Bowers
Lee Bowers
Director, Baltimore District
cc: Marsha Johnson Evans
President & CEO
American National Red Cross
2025 E Street, N.W.
Washington, D.C. 20006
C. William Cherry
Senior Vice President
for Quality and Regulatory Affairs
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
Bonnie McElveen-Hunter
Chairman, Board of Governors
American National Red Cross
2025 E Street, N.W.
Washington, D.C. 20006
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