[Federal Register Volume 62, Number 150 (Tuesday, August 5, 1997)]
[Notices]
[Page 42134]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-20494]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0015]
Personal Blood Storage of Memphis, Inc.; Revocation of U.S.
License No. 1131
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. 1131) and the
product licenses issued to Personal Blood Storage of Memphis, Inc., for
the manufacture of Whole Blood, Red Blood Cells, Plasma, and Platelets.
Personal Blood Storage of Memphis, 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.
1131) and the product licenses is effective August 5, 1997.
FOR FURTHER INFORMATION CONTACT: Gloria J. Hicks, 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. 1131) and the product licenses issued to Personal
Blood Storage of Memphis, Inc., formerly located at 5182 East Raines
Rd., Memphis, TN 38118, for the manufacture of Whole Blood, Red Blood
Cells, Plasma, and Platelets.
An attempted onsite inspection by FDA on May 23, 1995, revealed
that the facility was no longer in operation at the location listed on
the license. An FDA investigator, from the Nashville District Office,
was permitted to visit the unoccupied facility on August 3, 1995. The
investigator documented that the office space and two walk-in freezers
were empty and there was no electrical or water service at the
facility. 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). The
U.S. Postal Service supplied FDA with the firm's forwarding address,
and FDA sent a certified letter, dated September 8, 1995, to the firm's
responsible head providing notice of FDA's intent to revoke the
licenses and its intent to offer an opportunity for a hearing on the
proposed revocation. The responsible head responded by telephone on
September 12, 1995, and said that she was no longer employed by
Personal Blood Storage of Memphis, Inc. She also sent a copy of a March
3, 1995, letter to the Center for Biologics Evaluation and Research
(CBER), in which she stated that she was no longer the technical
director or responsible head for Personal Blood Storage of Memphis,
Inc. A copy of FDA's letter of intent to revoke U.S. License No. 1131
was also sent to one owner's address in Texas and this letter was
returned by the U.S. Postal Service as unclaimed.
Under Sec. 12.21(b) (21 CFR 12.21(b)), FDA published in the Federal
Register of April 24, 1996 (61 FR 18149), a notice of opportunity for a
hearing on a proposal to revoke the licenses of Personal Blood Storage
of Memphis, Inc. 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,
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 written
comments on the proposed revocation. The firm did not respond within
the 30-day time period with a written request for a hearing. Under
Sec. 12.21(b), 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(a)(1), 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, CBER (21 CFR 5.67), the establishment license (U.S. License
No. 1131), and the product licenses issued to Personal Blood Storage of
Memphis, Inc., are revoked, effective August 5, 1997.
This notice is issued and published under 21 CFR 601.8.
Dated: July 28, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-20494 Filed 8-4-97; 8:45 am]
BILLING CODE 4160-01-F
