[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