[Federal Register Volume 60, Number 73 (Monday, April 17, 1995)]
[Notices]
[Pages 19265-19266]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-9412]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
 [Docket No. 93N-0122]


Hema Systems, Ltd.; Revocation of U.S. License No. 1052

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. 1052) and 
product licenses (the licenses) issued to Hema Systems, Ltd., for the 
manufacture of Whole Blood, Plasma, Fresh Frozen Plasma, Red Blood 
Cells, Red Blood Cells Frozen, Red Blood Cells Deglycerolized, Red 
Blood Cells Leukocytes Removed, Red Blood Cells Frozen Rejuvenated, and 
Red Blood Cells Rejuvenated Deglycerolized. Hema Systems, 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. 
1052) and product licenses is effective April 17, 1995.

FOR FURTHER INFORMATION CONTACT: Stephen M. Ripley, Center for 
Biologics Evaluation and Research (HFM-635), 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. 1052) and product licenses issued to Hema Systems, 
Ltd., formerly located at 310 East 44th St., New York, NY 10017, for 
the manufacture of Whole Blood, Plasma, Fresh Frozen Plasma, Red Blood 
Cells, Red Blood Cells Frozen, Red Blood Cells Deglycerolized, Red 
Blood Cells Leukocytes Removed, Red Blood Cells Frozen Rejuvenated, and 
Red Blood Cells Rejuvenated Deglycerolized.
    An attempted onsite inspection by FDA on August 26, 1992, revealed 
that the facility was no longer in operation at the location listed on 
the license. The U.S. Post Office reported no forwarding address for 
the firm. 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). FDA 
issued a certified letter dated November 3, 1992, to the firm stating 
FDA's intent to revoke the licenses and its intent to offer an 
opportunity for a hearing on the proposed revocation. The letter was 
returned to FDA as undeliverable.
     Pursuant to 21 CFR 12.21(b), FDA published in the Federal Register 
of May 14, 1993 (58 FR 28589), a notice of opportunity for a hearing on 
a proposal to revoke the licenses of Hema Systems 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 the license revocation had been 
placed on file for public examination with the Dockets Management 
Branch (HFA-305), Food and Drug Administration, rm. 1-23, 12420 
Parklawn Dr., 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 
regulations, may not be extended. One comment was submitted from the 
State of New York Department of Health which indicated that the 
facility was closed according to their records.
    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), the establishment license 
(U.S. License No. 1052) and the product licenses issued to Hema 
Systems, Ltd., are revoked, effective April 17, 1995.
    This notice is issued and published under 21 CFR 601.8.

    [[Page 19266]] Dated: April 10, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-9412 Filed 4-14-95; 8:45 am]
BILLING CODE 4160-01-F