[Federal Register Volume 60, Number 82 (Friday, April 28, 1995)]
[Notices]
[Pages 20997-20998]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-10541]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 93N-0418]


United Blood Services Blood Systems, Inc.; Revocation of U.S. 
License No. 0183-020

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. 0183-020) and 
product licenses issued to United Blood Services Blood Systems, Inc. 
(BSI), for the manufacture of Whole Blood (ACD, CPD, CPDA-1), Red Blood 
Cells, Red Blood Cells Leukocytes Removed, Plasma, Fresh Frozen Plasma, 
Cryoprecipitated AHF, Platelets, Platelets Pheresis, and Source 
Leukocytes. BSI has numerous locations throughout the United States; 
the licenses have been revoked only at the BSI location at Texarkana, 
TX. In a letter to FDA dated June 28, 1993, BSI voluntarily requested 
the revocation of its establishment and product licenses and waived its 
opportunity for hearing.

DATES: The revocation of the establishment license (U.S. License No. 
0183-020) and the product licenses became effective July 23, 1993.

FOR FURTHER INFORMATION CONTACT: Jean M. Olson, 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 announcing the revocation of the 
establishment license (U.S. License No. 0183-020) and the product 
licenses issued to BSI, 1321 College Dr., Texarkana, TX 75503, for the 
manufacture of Whole Blood (ACD, CPD, CPDA-1), Red Blood Cells, Red 
Blood Cells Leukocytes Removed, Plasma, Fresh Frozen Plasma, 
Cryoprecipitated AHF, Platelets, Platelets Pheresis, and Source 
Leukocytes. The current mailing address is United Blood Services Blood 
Systems, Inc., c/o Blood Systems, Inc., 6210 East Oak St., P.O. Box 
1867, Scottsdale, AZ 85252. BSI has numerous locations throughout the 
United States. The licenses were revoked for the Texarkana, TX, 
location only. [[Page 20998]] 
    FDA conducted an inspection and concurrent investigation of BSI 
from March 23 through April 14, 1993. The inspection and concurrent 
inspection revealed serious deviations from the standards established 
in the applicable Federal regulations and approved license.
    The concurrent investigation revealed significant deficiencies that 
occurred routinely in quality control recordkeeping, as well as in 
personnel training and supervision. BSI employees, with the knowledge 
of management, falsified blood storage temperature records whenever the 
temperature was outside the range specified in written procedures. BSI 
employees also routinely discarded donor registration forms of 
temporarily deferred donors because the staff would receive negative 
performance evaluations if a high number of donors were deferred.
    During the inspection, FDA observed deviations that included, but 
were not limited to, the following: (1) Failure to determine donor 
suitability, in that BSI accepted donations from individuals who 
reported disqualifying information (21 CFR 640.3(b)); (2) failure to 
adequately prepare the donor's phlebotomy site by a method that gives 
maximum assurance of sterility, in that the site was sometimes 
repalpated after the arm scrub was performed, and the arm scrubs were 
performed for less than the 30 seconds required by BSI's standard 
operating procedures (21 CFR 640.4(f)); and (3) failure to assure that 
the personnel responsible for the collection of blood on mobile drives 
were adequate in number, in that it was observed that donors were 
rushed through medical history questions, were not provided with 
adequate privacy during medical history interviews, and were only 
allowed 1 to 2 minutes of recovery time following blood donation (21 
CFR 606.20(b)).
    The inspection observations and the concurrent investigation showed 
that BSI knowingly falsified blood storage records. Consequently, FDA 
determined that BSI willfully failed to comply with the standards 
established in the approved license and in the applicable regulations. 
In accordance with that determination, FDA initiated proceedings under 
21 CFR 601.5(b) for license revocation without providing BSI with an 
opportunity to achieve or demonstrate compliance.
    In a letter to BSI dated June 1, 1993, FDA delineated the 
observations listed above and announced its intent to offer an 
opportunity for a hearing on FDA's proposal to revoke U.S. License 
0183-020 issued to BSI. In a letter to FDA dated June 28, 1993, BSI 
requested voluntary revocation of its license and waived its 
opportunity for a hearing under 21 CFR 601.5(a). In a letter dated July 
23, 1993, FDA acknowledged voluntary revocation of the establishment 
license (U.S. License No. 0183-020) and the aforementioned product 
licenses of BSI at the Texarkana, TX, location.
    FDA has placed copies of documents relevant to the license 
revocation on file under the docket number found in brackets in the 
heading of this notice with the Dockets Management Branch (HFA-305), 
Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, 
MD 20857. These documents are available for public examination in the 
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.
    Accordingly, under 21 CFR 601.5, 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, Center for Biologics Evaluation and Research (21 CFR 5.68), 
the establishment license (U.S. License No. 0183-020) and product 
licenses for Whole Blood (ACD, CPD, CPDA-1), Red Blood Cells, Red Blood 
Cells Leukocytes Removed, Plasma, Fresh Frozen Plasma, Cryoprecipitated 
AHF, Platelets, Platelets Pheresis, and Source Leukocytes issued to BSI 
at the Texarcana, TX, location were revoked, effective July 23, 1993.
    This notice is issued and published under 21 CFR 601.8 and the 
redelegation at (21 CFR 5.67).

    Dated: April 8, 1995.
Kathryn C. Zoon,
Director, Center for Biologics Evaluation and Research.
[FR Doc. 95-10541 Filed 4-27-95; 8:45 am]
BILLING CODE 4160-01-F