Knickerbocker Biologicals, Inc.; Revocation of U.S. License No. 458-001

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