[Federal Register Volume 61, Number 20 (Tuesday, January 30, 1996)]
[Notices]
[Pages 3040-3042]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-1656]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95N-0155]
Bio-Components, Inc.; Opportunity for a Hearing on a Proposal to
Revoke U.S. License No. 1160
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for a hearing on a proposal to revoke the establishment
license (U.S. License No. 1160) and the product licenses issued to Bio-
Components Inc. (BCI), for the manufacture of Source Plasma and Source
Leukocytes. The proposed revocation is based on the firm's significant
and continued noncompliance with Federal biologics regulations and
standards included in the firm's license.
DATES: The firm may submit a written request for a hearing to the
Dockets Management Branch by February 29, 1996, and any data and
information justifying a hearing by April 1, 1996. Other interested
persons may submit written comments on the proposed revocation by April
1, 1996
ADDRESSES: Submit written requests for a hearing, any data and
information justifying a hearing, and any written comments on the
proposed revocation to the Dockets Management Branch (HFA-305), Food
and Drug Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD
20857.
FOR FURTHER INFORMATION CONTACT: Timothy W. Beth, Center for Biologics
Evaluation and Research (HFM-635),
[[Page 3041]]
Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-
1448, 301-594-3074.
SUPPLEMENTARY INFORMATION: FDA is proposing to revoke the establishment
license (U.S. License No. 1160) and the product licenses issued to Bio-
Components, Inc., 440 North Beach St., Daytona Beach, FL 32114, for the
manufacture of Source Plasma and Source Leukocytes. The proposed
revocation is based on the failure of BCI, and its responsible
management to conform to the Federal regulations applicable to the
manufacture of biological products.
FDA conducted an inspection of BCI between January 21, 1993, and
February 12, 1993. The inspection revealed deviations from the Federal
regulations in 21 CFR parts 600 through 640 and from the applicable
standards in the firm's license. FDA determined that these deviations
constituted a danger to public health. The deviations were listed in a
March 19, 1993, letter, from FDA to BCI which suspended the
establishment license (U.S. License No. 1160) and the product licenses
for the manufacture of Source Plasma and Source Leukocytes. The
deviations included, but were not limited to, the failure to assure
that: (1) Each donor's clinical post-immunization response to
stimulation red blood cells was evaluated by a qualified physician (21
CFR 640.66); (2) serum protein electrophoresis (SPE) and a serologic
test for syphilis were performed on each donor at least every 4 months
(21 CFR 640.65(b)(1)(i)); (3) a qualified physician approved the
plasmapheresis procedures of any donor whose SPE or rapid plasma reagin
(RPR) test sample had not been collected at the required 4-month
interval (21 CFR 640.65(b)(1)(ii)); (4) SPE results were reviewed by a
qualified physician within 21 days after the sample was drawn to
determine whether or not the donor may continue in the program (21 CFR
640.65(b)(2)(i)); (5) personnel had the capabilities commensurate with
their assigned functions (21 CFR 600.10(b) and 640.66); and (6)
adequate records were maintained to document unsuitable donors, and the
performance of each significant step in the collection, processing,
storage, and distribution of each unit of blood and blood components
(21 CFR 606.160(a), 606.160(b), and 606.160(e)).
FDA received corrective action plans from BCI in letters dated
March 26, 1993, and September 17, 1993. By letters dated May 19, 1993,
August 26, 1993, and December 3, 1993, FDA, among other things,
addressed BCI's proposed corrective action plans and provided the firm
with explanations of why its proposals were inadequate.
In the December 3, 1993, letter, pursuant to 21 CFR 600.10, FDA
informed BCI's responsible head that he had been deemed unsuitable for
that position or any position of authority at the firm. Factors
contributing to this decision included, but were not limited to: (1)
The deviations cited in regard to the January through February 1993
inspection that resulted in license suspension; (2) failure to submit
adequate corrective action plans; (3) failure to exercise control of
the establishment in all matters relating to compliance; (4) failure to
assure that personnel were adequately trained, properly supervised and
had a thorough understanding of the procedures that they performed; and
(5) a repeated history of license suspensions and revocations while
responsible head of two other blood establishments.
In the May 13, 1994, letter, FDA made clear that the nature of the
deficiencies at BCI, the firm's past history of noncompliance, the
firm's failure to submit an adequate corrective action plan, and the
unsuitability of the firm's responsible head demonstrated BCI's
careless disregard for the applicable regulations and the applicable
standards in its license. Due to this evidence of willfulness, based
upon the evidence of careless disregard, and pursuant to 21 CFR 601.6,
FDA was not required to provide BCI with further opportunity to correct
its deficiencies and achieve compliance with the applicable standards.
In a letter dated May 13, 1994, FDA informed BCI of the agency's
intent to revoke the firm's licenses and issue a notice of opportunity
for a hearing pursuant to 21 CFR 601.5(b). BCI did not contact FDA
within 10 days of receipt of the letter to voluntarily request
revocation of its licenses. Pursuant to 21 CFR 12.21(b), FDA is now
issuing a notice of opportunity for a hearing on a proposal to revoke
U.S. License No. 1160 and the product licenses issued to BCI for the
manufacture of Source Plasma and Source Leukocytes.
FDA has placed copies of letters supporting the proposed license
revocation on file in the Dockets Management Branch under the docket
number found in brackets in the heading of this notice. These documents
include the following: FDA letters of March 19, 1993, May 19, 1993,
August 26, 1993, December 3, 1993, May 13, 1994, and BCI letters of
March 26, 1993, September 17, 1993, December 13, 1993, and February 16,
1994. 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.
FDA procedures and requirements governing a notice of opportunity
for a hearing, notice of appearance and request for a hearing, grant or
denial of a hearing, and submission of data and information to justify
a hearing on proposed revocation of licenses are contained in 21 CFR
parts 12 and 601. A request for a hearing may not rely upon mere
allegations or denials but is required to set forth a genuine and
substantial issue of fact that requires a hearing. If it conclusively
appears from the face of the data, information, and factual analyses
submitted in support of the request for a hearing that there is no
genuine and substantial issue of fact for resolution at a hearing, the
Commissioner of Food and Drugs will deny the hearing request, making
findings and conclusions that justify the denial.
BCI may submit a written request for a hearing to the Dockets
Management Branch by February 29, 1996, and any data or information
justifying a hearing must be submitted by April 1, 1996. Other
interested persons may submit comments on the proposed license
revocation to the Dockets Management Branch by February 29, 1996. The
failure of a licensee to file a timely written request for a hearing
constitutes an election by the licensee not to avail itself of the
opportunity for a hearing concerning the proposed license revocation.
Two copies of any submissions are to be provided to FDA, except
that individuals may submit one copy. Submissions are to be identified
with the docket number found in brackets in the heading of this
document. Submissions, except for data and information prohibited from
public disclosure under 21 CFR 10.20(j)(2)(i), 21 U.S.C. 331(j), or 18
U.S.C. 1905, may be seen in the Dockets Management Branch (address
above) between 9 a.m. and 4 p.m., Monday through Friday.
This notice is issued under the Public Health Service Act (sec. 351
(42 U.S.C. 262)) and the Federal Food, Drug, and Cosmetic Act (secs.
201, 501, 502, 505, 701 (21 U.S.C. 321, 351, 352, 355, 371)) and under
authority delegated to the Commissioner of Food and Drugs (21 CFR 5.10)
and redelegated to the Director and Deputy Director, Center for
Biologics Evaluation and Research (21 CFR 5.67).
[[Page 3042]]
Dated: January 19, 1996.
Michael G. Beatrice,
Deputy Director, Center for Biologics Evaluation and Research.
[FR Doc. 96-1656 Filed 1-29-96; 8:45 am]
BILLING CODE 4160-01-F
