[Federal Register Volume 67, Number 232 (Tuesday, December 3, 2002)]
[Notices]
[Pages 71975-71976]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-30642]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0476]


Bavarian Red Cross; Revocation of U.S. License No. 1002

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
revocation of the biologics license (U.S. License No. 1002), issued to 
the Bavarian Red Cross (BRC), for the manufacture of Whole Blood and 
Red Blood Cells. In a letter to FDA dated June 3, 2002, BRC voluntarily 
requested revocation of its licenses without prejudice and thereby 
waived its opportunity for a hearing. In a letter dated July 22, 2002, 
FDA revoked the firm's license.

DATES: The revocation of the biologics license (U.S. License No. 1002) 
is effective July 22, 2002.

FOR FURTHER INFORMATION CONTACT: Michael D. Anderson, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6210.

SUPPLEMENTARY INFORMATION: FDA has revoked the biologics license (U.S. 
License No. 1002), issued to BRC, Herzog-Heinrich-Strasse 4, D-80336, 
Munich, Germany, for the manufacture of Whole Blood and Red Blood 
Cells. Additional locations affected by the revocation include: Prof.-
Ernst-Nathan-Str. 1, D-90419, Nurnburg, Germany; Klinikstrasse 5, D-
97070, Wurzburg, Germany; Dr. Franz-Strasse 3, D-95445, Bayreuth, 
Germany; Westheimer Strasse 80, D-86156, Augsburg, Germany; Nikolaus-
Fey-Strasse 32, D-97353, Wiesentheid, Germany; and Hoher Kreuz Weg 7, 
D-93055, Regensburg, Germany.
    FDA inspected four of the six licensed locations of the BRC from 
October 27 through November 13, 1997. The inspections were conducted at 
the Munich, Wiesentheid, Nurnberg, and Bayreuth facilities. During the 
inspections, FDA observed significant deviations from the standards 
established in the license as well as the applicable Federal 
regulations. The standards and regulations are designed to ensure the 
continued safety, purity, and potency of the manufactured product. FDA 
also determined that the firm had discontinued the manufacture of Whole 
Blood and Red Blood Cells intended for distribution in the United 
States. FDA concluded that a meaningful inspection of BRC's ability to 
appropriately manufacture products under the license could not be made. 
The deviations noted during the inspections included, but were not 
limited to, the following: (1) In violation of 21 CFR 640.3(b), donor 
suitability was not adequately determined, in that questions were not 
asked, concurrently with the direct questions on high risk behavior, 
for exclusion of donors who are at increased risk for human 
immunodeficiency virus-1 (HIV-1) group O infection; (2) in violation of 
Sec. Sec.  606.140, 610.40, and 610.45 (21 CFR 606.140, 610.40, and 
610.45), inspections of the Nurnburg and Munich facilities disclosed 
that the Abbott Prism system, a device that was not approved by FDA, 
was utilized to test for antibody to HIV types 1 and 2 plus O (anti-HIV 
1/2), the hepatitis B surface antigen (HBsAg), the antibody to 
hepatitis B core antigen (anti-HBc), and antibody to hepatitis C virus 
encoded antigen (anti-HCV). Additionally, blood and blood products were 
not tested for HIV-1 antigen and antibody to human lymphotropic virus 
type I (anti-HTLV-I); (3) in violation of Sec.  606.140, the New LAV-
Bolt I by Sanofi Diagnostics Pasteur, an HIV-1 western blot assay that 
was not approved by FDA, was used as an assay for reentry of donors; 
(4) in violation of Sec.  606.140, the New LAV-Bolt II by Sanofi 
Diagnostics Pasteur, an HIV-2 western blot assay that was not approved 
by FDA, was used as an assay for reentry of donors; and (5) in 
violation of 21 CFR 606.121(c)(5)(i), blood and blood products that 
were intended for transfusion and collected from paid donors were not 
labeled as to distinguish them from blood products collected from 
volunteer donors.
    In a letter dated July 8, 1998, and issued under Sec.  601.5(b) (21 
CFR 601.5(b)), FDA outlined the deviations noted at the inspection. FDA 
notified BRC of FDA's intent to revoke U.S. License No. 1002 and 
announced its intent to offer an opportunity for hearing unless the 
deviations were adequately addressed. In a letter to FDA dated July 30, 
1998, BRC addressed FDA's concerns about the inability to inspect 
products prepared under the U.S. License No. 1002.
    In a certified, return-receipt letter dated January 21, 1999, to 
BRC, FDA stated that the firm's July 30, 1998, response was inadequate 
to address all the violations that FDA documented at the inspections. 
FDA advised BRC that its response was unsatisfactory in that BRC had 
not provided a comprehensive corrective action plan, adequate to bring 
the firm into compliance with the applicable Federal standards and 
regulations. In the same letter, FDA suggested that the firm 
voluntarily request that U.S. License No. 1002 be revoked, and a new 
application be submitted at a later date.
    In a letter dated November 3, 2000, FDA notified BRC that since the 
receipt of the July 30, 1998, letter to FDA, FDA had not received any 
additional response from the firm. The letter stated under Sec.  
601.5(b)(2), FDA had provided a reasonable period for the firm to 
demonstrate or achieve compliance with the applicable standards 
established in the license and regulations before proceeding to 
initiate revocation of U.S. License No. 1002. Since BRC did not submit 
a response addressing the methods intended to demonstrate or achieve 
compliance and did not waive an opportunity for hearing, FDA notified 
the firm in the same letter of FDA's intent to revoke the license and 
to issue a notice of opportunity for hearing under 21 CFR 12.21(b).
    In the Federal Register of May 9, 2002 (67 FR 31348), FDA announced 
a notice of opportunity for a hearing on a proposal to revoke the 
biologics license (U.S. License No. 1002) issued to BRC. In a letter to 
FDA dated June 3, 2002, BRC voluntarily requested revocation of its 
licenses without prejudice and thereby waived its opportunity for a 
hearing. In a letter to BRC dated July 22, 2002, FDA revoked the firm's 
license.
    FDA had placed copies of the documents relevant to the revocation 
on file with the Dockets Management Branch (address above) under the 
docket number found in brackets in the heading of this document.
    Accordingly, under section 351 of the Public Health Service Act (42 
U.S.C. 262) and sections 201, 501, 502, 505, and 701 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352, 355, and 371), 
and under the authority delegated to the Commissioner of Food and Drugs 
(21 CFR 5.10) and redelegated to the Director of the Center for 
Biologics Evaluation and Research (21 CFR 5.202), the biologics license 
(U.S. License No. 1002) issued to BRC was revoked, effective July 22, 
2002.


[[Page 71976]]


    Dated: November 22, 2002.
Kathryn C. Zoon,
Director, Center for Biologics Evaluation and Research.
[FR Doc. 02-30642 Filed 12-2-02; 8:45 am]
BILLING CODE 4160-01-S