[Federal Register Volume 62, Number 175 (Wednesday, September 10, 1997)]
[Notices]
[Pages 47670-47671]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-23946]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 93N-0391]
Central Georgia Plasma Lab, Inc.; Revocation of U.S. License No.
0649-001
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 establishment license (U.S. License No. 0649-001) and
product license issued to Central Georgia Plasma Lab, Inc. (Central
Georgia), for the manufacture of Source Plasma. A notice of opportunity
for a hearing on a proposal to revoke the licenses was published in the
Federal Register of May 20, 1994 (59 FR 26503). Central Georgia
subsequently requested a hearing. However, in a letter dated July 12,
1996, the firm notified FDA that it had ceased operations effective
June 25, 1996, and voluntarily requested revocation of its licenses.
The request for an opportunity for a hearing on the issue of license
revocation became moot. FDA, therefore, proceeded to revoke the firm's
licenses.
DATES: The revocation of the establishment license (U.S. License No.
0649-001) and product license became effective August 21, 1996.
FOR FURTHER INFORMATION CONTACT: Valerie A. Butler, Center for
Biologics Evaluation and Research (HFM-630), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-594-
3074.
SUPPLEMENTARY INFORMATION: FDA has revoked the establishment license
(U.S. License No. 0649-001), which includes the product license issued
to Central Georgia Plasma Lab, Inc., 652 Third St., Macon, GA 31201,
for the manufacture of Source Plasma.
By letter dated May 27, 1993, FDA notified Central Georgia that it
was instituting proceedings to revoke U.S. License No. 0649-001, and
announced its intent to issue a notice of opportunity for a hearing.
Central Georgia responded in a letter of June 1, 1993, and advised FDA
that the firm did not wish to waive its opportunity for a hearing. In
the Federal Register of May 20, 1994 (59 FR 26503), FDA announced an
opportunity for a hearing on the proposal to revoke the establishment
and product license issued to Central Georgia. In the notice of
opportunity for a hearing, FDA described its finding that Central
Georgia had willfully not complied with the applicable standards and
regulations. As described in the notice of opportunity for a hearing,
the grounds for the proposed license revocation included the following:
(1) The results of FDA's inspections of the firm, beginning in 1981,
but most recently from July 1989 through February 1993; (2) a
determination by FDA that the deviations documented during the
inspections of the firm demonstrated significant noncompliance with the
applicable regulations and the standards and conditions established in
the firm's licenses; (3) a determination that the nature of the
deficiencies noted demonstrated the continuing failure of the
Responsible Head to exercise control of the establishment in all
matters relating to compliance and to assure that personnel are
adequately trained and properly supervised and have a thorough
understanding of the procedures that they perform, as required by 21
CFR 600.10(a) and 606.20(a). Documentation in support of the proposed
revocation had been placed on file for public examination with the
Dockets Management Branch (HFA-305), Food and Drug Administration,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.
[[Page 47671]]
Following publication of the notice of opportunity for a hearing
and in accordance with the procedures set forth in parts 12 and 601 (21
CFR parts 12 and 601), on June 15, 1994, the Responsible Head of
Central Georgia submitted a request for a hearing to the Dockets
Management Branch and, on July 15, 1994, provided additional
supplemental information to justify the request for a hearing.
While the request for a hearing was pending, the owner and former
Responsible Head of Central Georgia informed the agency by letter dated
July 12, 1996, that Central Georgia had closed its facility on June 24,
1996, and ceased operations effective June 25, 1996, and was
voluntarily surrendering both the establishment and product licenses.
FDA notified Central Georgia by letter of August 21, 1996, that the
licenses had been revoked.
Based on the voluntary surrender of U.S. License No. 0649-001,
Central Georgia's request for a hearing on the issue of license
revocation became moot. Central Georgia effectively waived an
opportunity for a hearing on the matter (Sec. 601.5(a)).
Accordingly, under Sec. 601.5(a), section 351 of the Public Health
Service Act (42 U.S.C. 262), and under authority delegated to the
Commissioner of Food and Drugs (21 CFR 5.10) and redelegated to the
Director, Center for Biologics Evaluation and Research (21 CFR 5.68),
the establishment license (U.S. License No. 0649-001) and the product
license issued to Central Georgia Plasma Lab, Inc., for the manufacture
of Source Plasma were revoked, effective August 21, 1996.
This notice is issued and published under Sec. 601.8 and the
redelegation at 21 CFR 5.67.
Dated: August 25, 1997.
Mark Elengold,
Acting Deputy Director, Center for Biologics Evaluation and Research.
[FR Doc. 97-23946 Filed 9-9-97; 8:45 am]
BILLING CODE 4160-01-F