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

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]

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