[Federal Register Volume 68, Number 132 (Thursday, July 10, 2003)]
[Notices]
[Pages 41162-41163]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-17410]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0232]


Universal Reagents, Inc.; Opportunity for Hearing on a Proposal 
to Revoke 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 an 
opportunity for hearing on a proposal to revoke the biologics license 
(U.S. License No. 0887) issued to Universal Reagents, Inc. (URI), for 
the manufacture of Source Plasma. The proposed revocation is based on 
the failure of the establishment and the product for which the license 
has been issued to conform to the applicable standards established in 
the license and in the regulations.

DATES: URI may submit a written or electronic request for a hearing to 
the Division of Dockets Management by August 11, 2003, and any data and 
information justifying a hearing by September 8, 2003. Other interested 
persons may submit written or electronic comments on the proposed 
revocation to the Division of Dockets Management by September 8, 2003.

ADDRESSES: Submit written requests for a hearing, any data and 
information justifying a hearing, and any written comments on the 
proposed revocation to the Division of Dockets Management (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852. Submit electronic requests or comments to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Nathaniel L. Geary, 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 is initiating proceedings to revoke the 
biologics license (U.S. License No. 0887) issued to URI, 2858 North 
Pennsylvania St., Indianapolis, IN 46202, for the manufacture of Source 
Plasma. The proposed revocation is based on the failure of URI to 
conform to the applicable standards established in its license and 
certain requirements of subchapter F, parts 600 to 640 (21 CFR parts 
600 to 640).

I. Findings

    FDA inspected URI between May 29 and June 3, 2002. Additionally, on 
June 7, 2002, FDA inspected Central Indiana Regional Blood Center, Inc. 
(CIRBC), Indianapolis, IN, which performs infectious disease testing 
for URI under a contract agreement. FDA determined, 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. FDA also documented that 
URI has willfully engaged in violative recordkeeping practices and 
falsified records it submitted to FDA. The deviations noted during the 
inspections included, but were not limited to, the following:
    1. In violation of Sec. Sec.  610.40(a) and 606.160(b)(2)(i), test 
results for Source Plasma units 0730900, 0730911, and 0730912 for the 
hepatitis B surface antigen (HBsAg) and the antibody to the human 
immunodeficiency virus types 1 and 2 (anti-HIV-1/2) were missing from 
the Transfer PC Mainframe Unit Rejection Report (a computer generated 
report). On June 3, 2002, URI provided the FDA investigator with what 
URI identified as the missing test results. According to these results, 
the HBsAg and anti-HIV-1/2 tests, which purportedly were performed by 
CIRBC, were negative for Source Plasma units 0730900, 0730911, and 
0730912. However, the document did not bear a date or time in the 
designated reporting fields. Contrary to the documents obtained at the 
URI inspection, FDA's inspection of CIRBC disclosed that the required 
testing for HBsAg and anti-HIV-1/2 was not completed or performed for 
these Source Plasma units.
    2. In violation of Sec. Sec.  610.40(a) and 606.160(b)(2)(i), HBsAg 
and anti-HIV-1/2 test results for Source Plasma unit 0729859 were 
missing on a Transfer Report and on a Testing Status Report. An 
additional notation on the Testing Status Report stated ``sample too 
old to complete testing.'' An additional record that FDA collected 
during the URI inspection, a Laboratory Request Form dated June 4, 
2001, that URI generated, showed that all test results for unit 
0729859, including HBsAg and anti-HIV-1/2 testing, were documented as 
``NR'' or nonreactive. During the closeout discussion on June 3, 2002, 
URI provided the FDA investigator with a Testing Status Report stating 
that the testing had been performed at CIRBC and that test results for 
HBsAg and anti-HIV-1/2 were ``N'' or negative for unit 0729859. 
Contrary to the documents obtained at the URI inspection, FDA's 
inspection of CIRBC disclosed that infectious disease testing for HBsAg 
and anti-HIV-1/2 was not performed on Source Plasma unit 0729859.
    3. In violation of Sec.  606.160(b)(2)(i), URI failed to maintain 
anti-HIV-1/2 re-testing results for Source Plasma unit 0729718. On a 
Transfer Report dated May 5, 2001, Source Plasma unit 0729718 tested 
reactive for anti-HIV-1/2 in testing conducted by CIRBC. Rather than 
producing the results of re-testing on that unit, however, URI provided 
the FDA investigator, during the closeout discussion on June 3, 2002, 
with a Testing Status Report for unit 0729718 that noted an ``N'' or 
``nonreactive'' test result for the initial anti-HIV-1/2 test. No date 
or time was documented on the report; however, a notation on the report 
stated that it was reviewed by URI on May 9, 2000 [sic]. The sequence 
number noted on the report was 7899. FDA's inspection of CIRBC 
disclosed that all infectious disease testing related to anti-HIV-1/2 
that CIRBC performed on unit 0729718 in 2001 was associated with 
sequence number 1995, not 7899. CIRBC's records showed that anti-HIV-

[[Page 41163]]

1/2 testing for unit 0729718 was performed on or about May 5, 2001, and 
the result was reactive. CIRBC's records showed that the results of 
repeat duplicate anti-HIV-1/2 tests on unit 0729718, conducted on May 
7, 2001, were negative.
    In a certified, return-receipt letter dated October 23, 2002, and 
issued under Sec.  601.5(b), FDA outlined the deviations noted at the 
inspection of URI. FDA notified URI of FDA's intent to revoke U.S. 
License No. 0887 and announced the agency's intent to offer an 
opportunity for hearing. In situations involving willfulness, FDA need 
not provide an opportunity for the licensee to demonstrate or achieve 
compliance. FDA acknowledged receipt of URI's June 7, 2002, response to 
the Form FDA-483 for the May 29 to June 3, 2002, inspection to which 
URI had attached copies of the same falsified and discrepant records 
that URI previously provided to the FDA investigator during the 
inspection. FDA's review of the response disclosed continuing 
inconsistencies with the results of the inspection and investigation.
    Based on FDA's inspectional and investigational results, FDA has 
determined that URI willfully engaged in violative recordkeeping 
practices and provided false manufacturing records to FDA as corrective 
actions for the previously noted deficiencies. Additionally, URI's June 
7, 2002, response to the Form FDA-483 demonstrates that URI willfully 
continued to submit falsified documents to FDA.
    FDA also notes that URI has had a history of noncompliance with the 
applicable standards and regulations as shown by significant deviations 
that were documented during previous inspections of URI. Among those 
various deviations were discrepancies in URI's test result records, 
including discrepancies in the test results for the antibody to HIV 
type 1. FDA emphasized the seriousness of URI's various deviations in 
letters to URI, including a notice of adverse findings letter dated 
October 20, 1988, a notice of adverse findings letter dated September 
26, 1989, a warning letter dated October 19, 1992, and a warning letter 
dated July 20, 2000.

II. Notice of Opportunity for Hearing

    Because URI did not submit a response to the FDA letter dated 
October 23, 2002, and did not waive an opportunity for hearing under 21 
CFR 12.21(b), FDA is issuing a notice of opportunity for hearing on a 
proposal to revoke the biologics license (U.S. License No. 0887) issued 
to URI for Source Plasma.
    FDA has placed copies of the documents relevant to the proposed 
revocation on file with the Division of Dockets Management (see 
ADDRESSES) under the docket number found in brackets in the heading of 
this document. These documents include FDA's letters to URI dated 
October 20, 1988, September 26, 1989, October 19, 1992, July 20, 2000, 
and October 23, 2002, and URI's response to FDA dated June 7, 2002. 
These documents are available for public examination in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
    FDA procedures and requirements governing a notice of opportunity 
for a hearing, notice of appearance and request for a hearing, grant or 
denial of a hearing, and submission of data and information to justify 
a hearing on a proposed revocation of a license are contained in parts 
601 and 12 (21 CFR part 12). In requesting a hearing, a person must 
submit to FDA's Division of Dockets Management objections and a request 
for a hearing on each objection, along with a detailed description and 
analysis of the factual information to be presented in support of each 
objection, as provided in Sec.  12.22. A deficient request or objection 
will be returned; however, the deficient submission may be supplemented 
and subsequently filed if submitted within the 30-day time period 
(Sec.  12.22(c)). The objections should identify the specific fact or 
facts that are genuine, substantial, and in dispute (Sec.  
12.24(b)(1)). Mere allegations or denials are not enough to obtain a 
hearing (Sec.  12.24(b)(2)). The Commissioner of Food and Drugs (the 
Commissioner) will deny the hearing request if the Commissioner 
concludes that the data and information submitted are insufficient to 
justify the factual determination urged, even if accurate (Sec.  
12.24(b)(3)).
    Two copies of any submissions are to be provided to FDA, except 
that individuals may submit one copy. Submissions are to be identified 
with the docket number found in brackets in the heading of this 
document. Submissions, except for data and information prohibited from 
public disclosure under 21 U.S.C. 331(j) or 18 U.S.C. 1905, may be 
examined in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday.
    This notice is issued under section 351 of the Public Health 
Service Act (42 U.S.C. 262) and sections 201, 501, 502, 505, 701 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352, 355, and 
371), and under authority delegated to the Commissioner (21 CFR 5.10) 
and redelegated to the Director of the Center for Biologics Evaluation 
and Research (21 CFR 5.202).

    Dated: June 30, 2003.
Jesse Goodman,
Director, Center for Biologics Evaluation and Research.
[FR Doc. 03-17410 Filed 7-9-03; 8:45 am]
BILLING CODE 4160-01-S