[Federal Register Volume 60, Number 73 (Monday, April 17, 1995)]
[Notices]
[Page 19266]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-9410]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 93N-0109]
Houston Apheresis, Inc.; Revocation of U.S. License No. 990
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. 990) and
product licenses (the licenses) issued to Houston Apheresis, Inc., for
the manufacture of Whole Blood, Red Blood Cells, Plasma, and Fresh
Frozen Plasma. Houston Apheresis, Inc., 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.
990) 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. 990) and product licenses issued to Houston
Apheresis, Inc., formerly located at 9265 Kirby Dr., Houston, TX 77054,
for the manufacture of Whole Blood, Red Blood Cells, Plasma, and Fresh
Frozen Plasma.
An attempted onsite inspection by FDA on March 26, 1991, revealed
that the facility was no longer in operation at the location listed on
the license. A forwarding address, obtained from the post office for
the facility, was the home address of the Responsible Head. An FDA
investigator left messages for the Responsible Head requesting that the
agency be contacted; however, the messages were not returned. Based on
the inability of authorized FDA employees to conduct an inspection of
the facility after reasonable efforts, FDA initiated proceedings for
the revocation of the licenses under 21 CFR 601.5(b). FDA issued a
certified letter, dated October 26, 1992, to the Responsible Head of
the firm, providing notice of FDA's intent to revoke the licenses and
its intent to offer an opportunity for a hearing on the proposed
revocations.
Pursuant to 21 CFR 12.21(b), FDA published in the Federal Register
of May 18, 1993 (58 FR 28982), a notice of opportunity for a hearing on
a proposal to revoke the licenses of Houston Apheresis, Inc. In the
notice, FDA explained that the proposed license revocation was based on
the inability of authorized FDA employees to conduct an inspection of
the facility, which 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 with 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. No other interested persons submitted
written comments on the proposed revocation within the 60-day time
period.
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. 990) and the product licenses issued to Houston
Apheresis, Inc., for the manufacture of Whole Blood, Red Blood Cells,
Plasma, and Fresh Frozen Plasma, are revoked, effective April 17, 1995.
This notice is issued and published under 21 CFR 601.8 and 12.38.
Dated: April 10, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-9410 Filed 4-14-95; 8:45 am]
BILLING CODE 4160-01-F
