[Federal Register Volume 61, Number 99 (Tuesday, May 21, 1996)]
[Notices]
[Pages 25495-25496]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-12688]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 92N-0438]
Worldwide Biologicals, Inc.; Revocation of U.S. License No. 832-
003
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. 832-003) and
the product license issued to Worldwide Biologicals, Inc., 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 March 22, 1993. Worldwide Biologicals, Inc., subsequently requested
a hearing. In a separate legal proceeding, the responsible head of
Worldwide Biologicals, Inc., voluntarily surrendered U.S. License No.
832-003 pursuant to a plea agreement with the United States Attorney
for the Southern District of Ohio and the Office of Consumer
Litigation, United States Department of Justice, which represented FDA
in the proceeding. In light of Worldwide Biologicals, Inc.'s, surrender
of its license, the firm's request for an opportunity for a hearing on
the issue of license revocation became moot. FDA, therefore, proceeded
to revoke the licenses.
DATES: The revocation of the establishment license (U.S. License No.
832-003) and product license became effective September 29, 1994.
FOR FURTHER INFORMATION CONTACT: Stephen M. Ripley or Tracey H. Forfa,
Center for Biologics Evaluation and Research (HFM-635), Food and Drug
Administration, 1401 Rockville Pike,
[[Page 25496]]
Rockville, MD 20852-1448, 301-594-3074.
SUPPLEMENTARY INFORMATION: FDA has revoked the establishment license
(U.S. License No. 832-003) and the product license for the manufacture
of Source Plasma issued to Worldwide Biologicals, Inc., 508-A Owen Dr.,
Fayetteville, NC 28304.
By letter dated June 15, 1992, issued pursuant to 21 CFR 601.5(b),
FDA notified the firm of FDA's intent to revoke U.S. License No. 832-
003 and announced its intent to offer an opportunity for a hearing. In
a facsimile dated June 24, 1992, the firm notified FDA of its intent to
request a hearing on the proposed license revocation.
In the Federal Register of March 22, 1993 (58 FR 15351), FDA issued
a notice of opportunity for a hearing, pursuant to 21 CFR 12.21(b), on
the proposal to revoke the establishment license (U.S. License No. 832-
003) and product license issued to Worldwide Biologicals, Inc., 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 FDA inspections of the firm conducted
from June 24 through July 2, 1991; January 17 through January 27, 1992;
and May 5 and 6, 1992; as well as from the inspection of Worldwide
Biologicals, Inc., 1085 Ohio Pike, Cincinnati, OH, the site of the
testing laboratory approved to perform all required testing for the
Fayetteville facility, from July 18 through August 26, 1991; (2) a
determination by FDA that the deviations documented during the
inspections of the firm demonstrated significant noncompliance with the
applicable regulations and standards in the firm's license; and (3) a
determination by FDA that there was no assurance that the firm would
properly implement a corrective action plan that it had proposed. FDA's
determination was based on the firm's failure to adequately implement
previously promised corrections. 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,
rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857.
Following publication of the notice of opportunity for a hearing on
March 22, 1993, FDA's Dockets Management Branch received two letters,
dated April 12, 1993, and May 20, 1993, from the firm's responsible
head. In the letter of April 12, 1993, Worldwide Biologicals, Inc.,
requested a hearing on the proposed license revocation. In the letter
of May 20, 1993, Worldwide Biologicals, Inc., submitted its request for
a hearing and set forth information and factual analyses to support its
request.
While the request for a hearing was pending, representatives of the
U.S. Department of Justice, on behalf of FDA, charged the responsible
head of Worldwide Biologicals, Inc., with criminal violations of
Federal laws governing the manufacturing, labeling, and shipping of
human blood plasma. On April 6, 1994, the responsible head entered into
a plea agreement with the United States Attorney for the Southern
District of Ohio and the Office of Consumer Litigation, United States
Department of Justice. In a superseding plea agreement filed on April
29, 1994, with the clerk of the United States District Court, Southern
District of Ohio, Western Division, the responsible head of the firm
agreed to surrender U.S. License No. 832 immediately upon sentencing.
Sentencing took place on September 23, 1994. FDA notified Worldwide
Biologicals, Inc., by letter of September 29, 1994, that the licenses
had been revoked.
Based on the voluntary surrender of U.S. License No. 832, Worldwide
Biologicals Inc.'s request for a hearing on the issue of license
revocation became moot. Although the revocation proceedings that FDA
initiated only pertained to the firm's Fayetteville, NC location (U.S.
License No. 832-003), the surrender of U.S. License No. 832 affects all
Worldwide Biologicals, Inc., locations under that license.
Accordingly, under 21 CFR 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 (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. 832-003) and the product
license for the manufacture of Source Plasma issued to Worldwide
Biologicals, Inc., were revoked, effective September 29, 1994.
This notice is issued and published under 21 CFR 601.8 and the
redelegation at 21 CFR 5.67.
Dated: May 2, 1996.
Kathryn C. Zoon,
Director, Center for Biologics Evaluation and Research.
[FR Doc. 96-12688 Filed 5-20-96; 8:45 am]
BILLING CODE 4160-01-F