Personal Blood Storage of Memphis, Inc.; Revocation of U.S. License No. 1131

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.

-----------------------------------------------------------------------

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