[Federal Register Volume 60, Number 230 (Thursday, November 30, 1995)]
[Notices]
[Pages 61559-61560]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-29220]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95N-0026]
Blood Systems Inc., United Blood Services; Revocation of U.S.
License No. 183-009
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. 183-009) and
the product licenses issued to Blood Systems, Inc., United Blood
Services, now doing business as Blood Systems, Inc., for the
manufacture of Whole Blood, Red Blood Cells, Plasma, Cryoprecipitated
antihemophilic factor (AHF), Platelets, and Source Leukocytes. Blood
Systems, Inc., United Blood Services has several locations; only the
Lubbock, TX, location is affected by this revocation. In a letter to
FDA dated June 8, 1994, the firm voluntarily requested revocation of
its establishment license and product licenses at the Lubbock, TX,
location and thereby waived an opportunity for a hearing.
DATES: The revocation of the establishment license (U.S. License No.
183-009) and the product licenses became effective July 19, 1994.
FOR FURTHER INFORMATION CONTACT: Sharon Carayiannis, 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 has revoked the establishment license
(U.S. License No. 183-009) and the product licenses issued to Blood
Systems, Inc., United Blood Services, 2523 48th St., Lubbock, TX 79413,
for the manufacture of Whole Blood, Red Blood Cells, Plasma,
Cryoprecipitated AHF, Platelets, and Source Leukocytes. The firm's
other locations are not affected by this revocation. Blood Systems,
Inc., United Blood Services submitted a notice of corporate name change
and is now doing business as Blood Systems, Inc.
FDA conducted an inspection of Blood Systems Inc., United Blood
[[Page 61560]]
Services, Lubbock, TX, from March 16 through March 25, 1994. The
inspection also involved a concurrent investigation which included
interviews with individuals knowledgeable about the firm's operations.
The inspection and the investigation documented serious deviations from
the applicable Federal regulations. Deviations identified in the
inspection included, but were not limited to, the following: (1)
Failure to collect blood by aseptic methods in a sterile system to
protect against contamination (21 CFR 640.4(f)), in that: (a) current
and former employees stated in affidavits that on numerous occasions
employees broke the sterility barrier of blood containers and drained
blood into vacutainer tubes or biohazard containers in order to conceal
overbleeds, and (b) employees used an incorrect phlebotomy technique on
numerous occasions thereby possibly contaminating the blood collection
bags with room air; (2) failure to maintain records of donor adverse
reaction reports (21 CFR 606.160(b)(1)(iii)), in that, on numerous
occasions, employees did not document mild to moderate donor adverse
reactions; (3) failure to follow standard operating procedures to
adequately determine donor suitability (21 CFR 606.100(b)(1)), in that
employees stated that: (a) donors were not always asked screening
questions, such as high risk behavior questions, in order to expedite
the donation process, (b) donors were sometimes asked if anything had
changed since the last time they donated instead of being asked the
required acquired immune deficiency syndrome (AIDS)-related behavior
questions, and (c) individuals under the influence of alcohol were
accepted as blood donors; and (4) failure to adequately and promptly
notify the Director, Center for Biologics Evaluation and Research, of
such errors or accidents in the manufacture of products that may affect
the safety, purity or potency of any product pursuant to 21 CFR 600.14,
in that, all known facts of the incidents involving a phlebotomist who
used an incorrect phlebotomy technique, whereby the units may have
become contaminated with room air, were not reported to the agency.
FDA determined that the deviations from Federal regulations were
significant and constituted a danger to public health, warranting a
suspension pursuant to 21 CFR 601.6(a). In a letter to Blood Systems,
Inc., United Blood Services, dated June 6, 1994, FDA detailed the
violations noted earlier in this document and suspended the firm's
establishment and product licenses. In the same letter, FDA
acknowledged receipt of letters dated April 13, April 15, and May 24,
1994, submitted by the firm in response to the Form FDA-483,
Inspectional Observations, left at the close of the inspection. FDA
concluded that the firm's promises of corrective action were not
sufficient based on the seriousness of the documented deviations. It
was FDA's view that the establishment and products failed to conform to
applicable donor protection standards which are intended to ensure a
continuous and healthy donor population, as well as standards designed
to ensure the continued safety, purity, potency, and quality of
products manufactured.
FDA's letter dated June 6, 1994, also stated that the agency's
inspection and investigational findings, including evidence that
records were knowingly falsified, demonstrated willfulness on the part
of the firm. As a result, pursuant to 21 CFR 601.5(b) the firm was not
given additional time to achieve compliance with the regulations. The
same letter provided notice that FDA intended to initiate proceedings
to revoke U.S. License No. 183-009 and product licenses issued to Blood
Systems, Inc., United Blood Services pursuant to 21 CFR 601.5(b) and
provided notice of opportunity for a hearing pursuant to 21 CFR
12.21(b). In a letter to FDA dated June 8, 1994, Blood Systems, Inc.,
voluntarily requested that its licenses for the Lubbock, TX, location
be revoked and thereby waived its opportunity for a hearing. In a
letter to the firm dated July 13, 1994, FDA acknowledged voluntary
revocation of the establishment license (U.S. License No. 183-009) and
the aforementioned product licenses of Blood Systems, Inc., United
Blood Services at the Lubbock, TX, location only. In the July 13, 1994,
letter to the firm, FDA restricted the interstate distribution of
autologous units currently in inventory except in documented emergency
situations, and permitted the firm to resume collections of allogeneic
and autologous blood products intended for distribution within the
State of Texas.
FDA has placed copies of letters relevant to the license
revocations on file under the docket number found in brackets in the
heading of this document in 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 (address above) between 9 a.m. and 4 p.m.,
Monday through Friday.
Accordingly, under section 351 of the Public Health Act (42 U.S.C.
262), 21 CFR 601.5, 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. 183-009) and the product licenses issued to
the Lubbock, TX, location of Blood Systems, Inc., United Blood Services
for the manufacture of Whole Blood, Red Blood Cells, Plasma,
Cryoprecipitated AHF, Platelets, and Source Leukocytes, were revoked,
effective July 19, 1994.
This notice is issued and published under 21 CFR 601.8 and under
authority delegated to the Director, Center for Biologics Evaluation
and Research (21 CFR 5.67).
Dated: October 31, 1995.
Michael G. Beatrice,
Deputy Director, Center for Biologics Evaluation and Research.
[FR Doc. 95-29220 Filed 11-29-95; 8:45 am]
BILLING CODE 4160-01-F
