[Federal Register Volume 63, Number 118 (Friday, June 19, 1998)]
[Notices]
[Page 33680]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-16294]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0384]
Knickerbocker Biologicals, Inc.; Revocation of U.S. License No.
458-001
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. 458-001) and
the product licenses issued to Knickerbocker Biologicals, Inc., for the
manufacture of Whole Blood, Red Blood Cells, Plasma, and Source
Leukocytes. Knickerbocker Biologicals, Inc., did not respond to a
notice of opportunity for a hearing on a proposal to revoke its
licenses.
DATES: The revocation of the establishment license (U.S. License No.
458-001) and the product licenses is effective June 19, 1998.
FOR FURTHER INFORMATION CONTACT: Astrid L. Szeto, 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 revoking the establishment license
(U.S. License No. 458-001) and the product licenses issued to
Knickerbocker Biologicals, Inc., doing business as Knickerbocker Blood
Bank, 272 Willis Ave., Bronx, NY 10454, for the manufacture of Whole
Blood, Red Blood Cells, Plasma, and Source Leukocytes.
An attempted inspection of the facility by FDA revealed that the
facility was no longer in operation at the location listed on the
license. A certified, returned-receipt letter from FDA dated November
14, 1996, notifying the Responsible Head of the unsuccessful inspection
and requesting the status of the firm was returned to the agency as
``undeliverable; address unknown''. A later attempt by FDA to visit
three other known addresses of Knickerbocker Biologicals, Inc., New
York, NY, verified that the company was no longer in business at these
locations. The respective post office for each location was also
visited and each verified that no information regarding either a
forwarding address or address change was available. Based on the
inability of authorized FDA employees to conduct a meaningful
inspection of the facility, FDA initiated proceedings for the
revocation of the licenses under 21 CFR 601.5(b)(1) and (b)(2). A
certified, returned-receipt letter, dated January 24, 1997, to the
firm's Responsible Head providing notice of FDA's intent to revoke the
licenses and its intent to offer an opportunity for a hearing on the
proposed revocation was returned as undeliverable.
Under 21 CFR 12.21(b), FDA published in the Federal Register of
October 6, 1997 (62 FR 52135), a notice of opportunity for a hearing on
a proposal to revoke the licenses of Knickerbocker Biologicals, Inc. In
the notice, FDA explained that the proposed license revocation was
based on the inability of authorized FDA employees to conduct a
meaningful inspection of the facility because it was no longer in
operation and noted that documentation in support of the license
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. The notice provided
the firm 30 days to submit a written request for a hearing and 60 days
to submit any data and information justifying a hearing. The notice
provided other interested persons with 60 days to submit written
comments on the proposed revocation. The firm did not respond within
the 30-day time period with a written request for a hearing. The 30-day
time period, prescribed in the notice of opportunity for a hearing and
in the regulation, may not be extended. No comments were received from
any other parties within the 60-day time period.
Accordingly, under 21 CFR 12.38, 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. 458-001), and the product
licenses issued to Knickerbocker Biologicals, Inc., are revoked,
effective June 19, 1998.
Dated: May 28, 1998.
Kathryn C. Zoon,
Director, Center for Biologics Evaluation and Research.
[FR Doc. 98-16294 Filed 6-18-98; 8:45 am]
BILLING CODE 4160-01-F