[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