[Federal Register Volume 62, Number 197 (Friday, October 10, 1997)]
[Notices]
[Page 53011]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-26987]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0115]


SEF, P.A.; Revocation of U.S. License No. 1166

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. 1166) and the 
product licenses issued to SEF, P.A., doing business as National Health 
Guard, Inc., for the manufacture of Whole Blood and Red Blood Cells 
(RBC's). SEF, P.A., 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. 
1166) and the product licenses is effective October 10, 1997.

FOR FURTHER INFORMATION CONTACT: Dano B. Murphy, 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 is revoking the establishment license 
(U.S. License No. 1166) and product licenses issued to SEF, P.A., doing 
business as National Health Guard, Inc., 1885 West Commercial Blvd., 
suite 140, Fort Lauderdale, FL 33309, for the manufacture of Whole 
Blood (CPDA-1) and RBC's including frozen, deglycerolized, frozen 
rejuvenated, and rejuvenated deglycerolized RBC's.
    On February 13, 1996, FDA attempted to inspect the SEF, P.A., 
facility located at 1820 North University Dr., Plantation, FL. The 
facility was found to be vacant. A visit that same day to the firm's 
previous business address, 1885 West Commercial Blvd., suite 140, Fort 
Lauderdale, FL, found that location to be vacant as well. On February 
28, 1996, the owner of SEF, P.A., stated that all the firm's equipment 
was stored in a warehouse in Miami, FL. The owner also indicated that 
he would voluntarily surrender the firm's license because SEF, P.A. was 
no longer in operation and there were no plans to resume operations. On 
June 17, 1996, FDA successfully contacted the owner by telephone and he 
indicated that he no longer desired to relinquish the license. Further 
attempts to contact the owner on July 2 and 29, 1996, were 
unsuccessful. On both occasions, messages were left with the answering 
party that were never replied to by the owner.
    FDA sent a certified, return-receipt letter dated November 1, 1996, 
to the firm's owner. The letter stated that under 21 CFR 601.5(b) a 
license may be revoked when the Commissioner of Food and Drugs finds 
that: (1) Authorized FDA employees after reasonable efforts have been 
unable to gain access to an establishment or a location for the 
purposes of carrying out an inspection, or (2) manufacturing of 
products or of a product has been discontinued to an extent that a 
meaningful inspection or evaluation cannot be made. The letter provided 
the firm's owner notice of FDA's intent to revoke U.S. License No. 1166 
and announced FDA's intent to offer an opportunity for a hearing.
    Under 21 CFR 12.21(b), FDA published in the Federal Register of 
April 9, 1997 (62 FR 17193), a notice of opportunity for a hearing on a 
proposal to revoke the licenses of SEF, P.A. In the notice, FDA 
explained that the proposed license revocation was based on the 
inability of 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 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.
    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. 1166) and the product 
licenses issued to SEF, P.A. are revoked, effective October 10, 1997.

    Dated: September 25, 1997.
Kathryn C. Zoon,
Director, Center for Biologics Evaluation and Research.
[FR Doc. 97-26987 Filed 10-9-97; 8:45 am]
BILLING CODE 4160-01-F