[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