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

June 10, 2005

MODIFIED ADVERSE DETERMINATION LETTER

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:

On May 16, 2005, the Food and Drug Administration (FDA) issued an Adverse Determination Letter (ADL) to the American Red Cross (ARC) assessing penalties pursuant to Paragraph X of the Amended Consent Decree of Permanent Injunction (Decree) entered on April 15, 2003. In accordance with Paragraph IX.A. of the Decree, ARC notified FDA by letter dated June 6, 2005, that it agrees with the May 16^th ADL, except for assessment of penalties for recall B-1280-4.

FDA has reevaluated its records regarding recall B-1280-4 and determined that it should not have been included in the list of recalls that was attached to the May 16^th ADL and that no penalties should have been assessed for that recall. In accordance with Paragraph IX.B. of the Decree, this letter modifies the May 16^th ADL, as follows:

1. FDA reviewed its database and files to identify classified ARC-conducted recalls. FDA identified 135 events in which ARC reported to FDA that they retrieved unsuitable blood components that were distributed during the period, April 15, 2003 through April 15, 2004.
2. The 135 events involved 9,945 unsuitable blood components.
3. The total number of unsuitable blood components for which FDA is assessing a penalty under Paragraph X.A.2. of the Decree is 1,442.
4. FDA has revised the amount of the penalty to reflect removal of recall B-1280-4. The total penalty amount is $3,405,000.
5. Recall B-1280-4 has been removed from the list of recalls attached to the May 16^th ADL. The revised list is attached to this letter.

Paragraph IX.B. of the Decree states, “If FDA affirms or modifies its determination, ARC shall, within 15 days of receipt thereof, either: (1) advise FDA in writing that it does not wish to appeal FDA’s determination, pay the penalties assessed and accrued under paragraph IX.A. above, and submit a plan and, when applicable, interim plan describing how and within what time frames ARC proposes to come into compliance with the law and this Order, or (2) appeal FDA’s determination to this Court.”

FDA acknowledges receipt of ARC's interim compliance plan which was attached to it’s June 6th letter. That interim plan is under review by FDA.

Your response to this letter 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., M.P.H., Director, Center for Biologics Evaluation and Research, 1401 Rockville Pike, Rockville, Maryland 20852.

Sincerely yours,

Evelyn Bonnin
Acting Director, Baltimore District

Attachment

cc: Marsha Johnson Evans
President and Chief Executive Officer
American National Red Cross
2025 E Street, N.W.
Washington, D.C. 20006

C. William Cherry
Senior Vice President for Quality
 and Regulatory Affairs
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

Bonnie McElveen-Hunter
Chairman, Board of Governors
American National Red Cross
2025 E Street, N.W.
Washington, D.C. 20006