[Federal Register: December 3, 2002 (Volume 67, Number 232)]
[Notices]
[Page 71975-71976]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03de02-100]
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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