[Federal Register Volume 69, Number 250 (Thursday, December 30, 2004)]
[Notices]
[Pages 78469-78470]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-28580]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0232]


Universal Reagents, Inc.; Revocation of U.S. License No. 0887

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. 0887) issued to 
Universal Reagents, Inc., (URI) for the manufacture of Source Plasma. A 
notice of opportunity for a hearing on a proposal to revoke the license 
was published in the Federal Register of July 10, 2003. URI requested a 
hearing by letter dated August 11, 2003. Subsequently, the authorized 
official of URI voluntarily requested revocation of its biologics 
license (U.S. License No. 0887) by letter dated December 29, 2003. In 
light of URI's request for revocation of its license, the firm's 
request for an opportunity for a hearing on the issue of license 
revocation became unnecessary. FDA, therefore, proceeded to revoke the 
license.

DATES: The revocation of U.S. License No. 0887 became effective March 
2, 2004.

FOR FURTHER INFORMATION CONTACT: Nathaniel L. Geary, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, suite 200N, 1401 Rockville Pike, Rockville, MD 20852-
1448, 301-827-6210.

SUPPLEMENTARY INFORMATION: FDA has revoked the biologics license (U.S. 
License No. 0887) for the manufacture of Source Plasma issued to URI, 
2858 North Pennsylvania St., Indianapolis, IN 46205.
    By certified return receipt letter, dated October 23, 2002, issued 
under Sec.  601.5(b) (21 CFR 601.5(b)), FDA notified the firm of FDA's 
intent to revoke U.S. License No. 0887 and announced its intent to 
offer an opportunity for a hearing. Because URI did not submit a 
response to FDA's letter dated October 23, 2002, and did not waive an 
opportunity for hearing under 21 CFR 12.21(b), FDA issued a notice of 
opportunity for a hearing in the Federal Register of July 10, 2003 (68 
FR 41162), on the proposal to revoke the biologics license (U.S. 
License No. 0887) issued to URI for the manufacture of Source Plasma. 
As described in the notice of opportunity for a hearing, the grounds 
for the proposed license revocation included the following: (1) The 
results of an FDA inspection of the firm conducted between May 29 and 
June 3, 2002; as well as from the inspection on June 7, 2002, of 
Central Indiana Regional Blood Center, Inc. (CIRBC), Indianapolis, IN, 
which performed infectious disease testing for URI under a contract 
agreement; (2) FDA's determination through its investigation and 
inspections of both URI and CIRBC, that URI had significant deviations 
from the standards established in its license as well as in the 
applicable Federal regulations; and (3) documentation that URI had 
willfully engaged in violative

[[Page 78470]]

recordkeeping practices and falsified records it submitted to FDA. In 
support of the proposed revocation, FDA had placed documentation on 
file for public examination with the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.
    Following publication of the notice of opportunity for a hearing on 
July 10, 2003, FDA's Division of Dockets Management received a letter 
(via electronic transmission), dated August 11, 2003. In the letter, 
URI requested a hearing on the proposed license revocation and set 
forth information to support its request.
    While the request for hearing was pending, the authorized official 
of the firm voluntarily requested revocation of U.S. License No. 0887 
by letter dated December 29, 2003. FDA notified URI by letter of March 
2, 2004, that the license had been revoked. Based on the voluntary 
request for revocation of U.S. License No. 0887, URI's request for a 
hearing on the issue of license revocation became unnecessary.
    Accordingly, under Sec.  601.5, section 351 of the Public Health 
Service Act (42 U.S.C. 262), and under authority delegated to the 
Commissioner of Food and Drugs (FDA Staff Manual Guides (SMG) 1410.10)) 
http://www.fda.gov/smg/default.htm and redelegated to the Director, 
Center for Biologics Evaluation and Research (SMG 1410.204), the 
biologics license (U.S. License No. 0887) for the manufacture of Source 
Plasma issued to URI was revoked, effective March 2, 2004.
    This notice is issued and published under Sec.  601.8 and the 
redelegation at SMG 1410.203.

    Dated: November 29, 2004.
Jesse Goodman,
Director, Center for Biologics Evaluation and Research.
[FR Doc. 04-28580 Filed 12-29-04; 8:45 am]
BILLING CODE 4160-01-S