[Federal Register Volume 65, Number 26 (Tuesday, February 8, 2000)]
[Notices]
[Pages 6213-6214]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-2768]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99N-0671]


Bestblood, Ltd.; Revocation of U.S. License No. 1116

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. 1116) and 
product licenses (the licenses) issued to Bestblood, Ltd., doing 
business as Optimum Healthcare, Inc., for the manufacture of Whole 
Blood, Red Blood Cells, Red Blood Cells Frozen, Whole Blood CPD, Red 
Blood Cells Deglycerolized, and Whole Blood CPDA-1. Bestblood, Ltd., 
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. 
1116) and product licenses is effective February 8, 2000.

FOR FURTHER INFORMATION CONTACT:  Joseph L. Okrasinski, Jr., 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. 1116) and product licenses issued to Bestblood, Ltd., 
doing business as Optimum Healthcare, Inc., 239 Randall St., San 
Francisco, CA 94131, for the manufacture of Whole Blood, Red Blood 
Cells, Red Blood Cells Frozen, Whole Blood CPD, Red Blood Cells 
Deglycerolized, and Whole Blood CPDA-1. Proceedings to revoke the 
licenses were initiated because an attempted inspection of the facility 
by FDA, as required under 21 CFR 600.21, revealed that the firm was no 
longer in operation.
    In a certified, return-receipt letter dated June 16, 1997, FDA 
notified the firm that the attempt to conduct an inspection at 
Bestblood, Ltd., 239 Randall St., San Francisco, CA 94131 was 
unsuccessful because the facility was apparently no longer in operation 
and requested that the firm notify FDA in writing of the firm's status. 
This letter was sent to 239 Randall St., San Francisco, CA 94131, and 
also to P.O. Box 843, Cupertino, CA 95054-0843,

[[Page 6214]]

and each was returned to the agency as undeliverable.
    In a certified, return-receipt letter sent to Bestblood, Ltd., 
dated March 4, 1998, at both addresses mentioned previously and 
returned as undeliverable, FDA indicated that an attempt to conduct an 
inspection at the facility was unsuccessful. The letter advised the 
firm that, under 21 CFR 601.5(b)(1) and (b)(2), when FDA finds that 
authorized employees have been unable to gain access to an 
establishment for the purpose of carrying out an inspection required 
under Sec. 600.21, or the manufacturing of products or of a product has 
been discontinued to an extent that a meaningful inspection cannot be 
made, proceedings for license revocation may be instituted. FDA also 
indicated that a meaningful inspection could not be made at the 
establishment and issued to the firm a notice of FDA's intent to revoke 
U.S. License No. 1116 and announced its intent to offer an opportunity 
for a hearing.
    Under 21 CFR 12.21(b), FDA published in the Federal Register of 
April 15, 1999 (64 FR 18623), a notice of opportunity for a hearing on 
a proposal to revoke the licenses of Bestblood, Ltd. 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 license revocation had been 
placed on file with the Dockets Management Branch (HFA-305), Food and 
Drug Administration, 5600 Fishers Lane, rm. 1061 Rockville, MD 20852. 
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 regulations, may not be extended. No other 
comments were received.
    Accordingly, under 21 CFR 12.38, section 351 of the Public Health 
Service Act (42 U.S.C. 262), and under the 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. 1116) and the product 
licenses issued to Bestblood, Ltd., are revoked, effective February 8, 
2000.

    Dated: January 13, 2000.
Mark Elengold,
Deputy Director for Operations, Center for Biologics Evaluation and 
Research.
[FR Doc. 00-2768 Filed 2-7-00; 8:45 am]
BILLING CODE 4160-01-F