[Federal Register Volume 67, Number 50 (Thursday, March 14, 2002)]
[Notices]
[Pages 11513-11514]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-6096]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1672]


Ashford Blood Bank, Inc.; Revocation of U.S. License No. 0740-001

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
revocation of the biologics license (U.S. License No. 0740-001) issued 
to Ashford Blood Bank, Inc., for the manufacture of Whole Blood and Red 
Blood Cells. Ashford Blood Bank, Inc., did not respond to a notice of 
opportunity for a hearing on a proposal to revoke its license.

DATES: The revocation of the biologics license (U.S. License No. 0740-
001) is effective March 14, 2002.

FOR FURTHER INFORMATION CONTACT: Joseph L. Okrasinski, Jr., Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6210.

SUPPLEMENTARY INFORMATION: FDA is revoking the biologics license (U.S. 
License No. 0740-001) issued to Ashford Blood Bank, Inc., Ashford 
Medical Center, suite 401-402, Santurce, PR 00907, for the manufacture 
of Whole Blood and Red Blood Cells. FDA initiated proceedings to revoke 
the biologics license because: (1) Authorized FDA employees were unable 
to gain access to either of the establishment's locations for the 
purpose of carrying out a required inspection of the facility as 
mandated under Sec. 600.21 (21 CFR 600.21), and (2) manufacturing of 
products had been discontinued to an extent that a meaningful 
inspection or evaluation could not be made. In a certified, return-
receipt letter dated October 28, 1997, FDA notified an authorized 
official of the firm that FDA had suspended the establishment's 
biologics license for the manufacture of Whole Blood and Red Blood 
Cells at its facilities at Santurce, PR, and Bayamon, PR. This action 
was based on the fact that significant deviations from the regulations 
were noted by FDA's San Juan district office during inspections of the 
facilities conducted August 19, 1997, through September 17, 1997, and 
September 9, 1997, through September 17, 1997, respectively. FDA's San 
Juan district office attempted to conduct additional inspections of the 
two Ashford facilities. On May 1, 1998, FDA investigators attempted to 
inspect the satellite collection facility at Bayamon, PR, but found 
that the facility was no longer in operation, and the manufacturing of 
Whole Blood and Red Blood Cells had been discontinued. On November 23, 
1999, FDA investigators attempted to inspect the main facility in 
Santurce, PR, but found that the facility was no longer in operation 
and the manufacturing of Whole Blood and Red Blood Cells had been 
discontinued.
    In certified, return-receipt letters dated April 13, 2000, sent to 
the establishment's facility at Santurce, PR, and also to the Ashford 
Blood Bank, Inc., P.O. Box 195034, San Juan, PR, 00919, FDA notified an 
authorized official of the firm that FDA's attempt to conduct 
inspections of the two facilities at Santurce, PR and Bayamon, PR were 
unsuccessful because the facilities were no longer in operation and the 
manufacture of Whole Blood and Red Blood Cells had been discontinued. 
The letter advised the establishment that, under Sec. 601.5(b)(l) and 
(b)(2) (21 CFR 601.5(b)(1) and (b)(2)) (now codified as 
Sec. 601.5(b)(1)(i) and (b)(1)(ii)), when FDA finds that authorized 
employees have been unable to gain access to an establishment for the 
purpose of carrying out an inspection required under Sec. 600.21, or 
the manufacturing of products or of a product has been discontinued to 
an extent that a meaningful inspection could not be made at the 
establishment, FDA may initiate proceedings for license revocation. FDA 
also stated that a meaningful inspection could not be made at the 
establishment's facilities and issued to the establishment a notice of 
FDA's intent to revoke U.S. License No. 0740-001 and announced its 
intent to offer an opportunity for a hearing.
    Under Sec. 12.21(b) (21 CFR 12.21(b)), FDA published in the Federal 
Register of February 6, 2001 (66 FR 9087), a notice of opportunity for 
a hearing on a proposal to revoke the biologics license of Ashford 
Blood Bank, 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 establishment because it was no 
longer in operation, and noted that documentation in support of license 
revocation had been placed on file with the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. The notice provided the establishment 30 days to 
submit a written request for a hearing and 60 days to submit any data 
and information

[[Page 11514]]

justifying a hearing. The notice provided other interested persons with 
60 days to submit written comments on the proposed revocation. The 
establishment did not respond within the 30-day time period with a 
written request for a hearing, and under Sec. 12.21(b), the 30-day time 
period prescribed in the notice of opportunity for a hearing may not be 
extended. No other comments were received.
    Accordingly, under 21 CFR 12.38, section 351 of the Public Health 
Service Act (42 U.S.C. 262), and under the authority delegated to the 
Commissioner of Food and Drugs (21 CFR 5.10), the biologics license 
(U.S. License No. 0740-001) issued to Ashford Blood Bank, Inc., is 
revoked, effective March 14, 2002.

    Dated: March 6, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-6096 Filed 3-13-02; 8:45 am]
BILLING CODE 4160-01-S