[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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the licenses have been revoked only at the BSI location at Texarkana,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
