[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
