[Federal Register Volume 60, Number 222 (Friday, November 17, 1995)]
[Notices]
[Pages 57719-57720]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-28367]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 94N-0376]


Plascon, Inc.; Opportunity for Hearing on a Proposal to Revoke 
U.S. License No. 572-003

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. 572-003) and the product license issued to 
Plascon, Inc., doing business as Anderson Plasma Center, for the 
manufacture of Source Plasma. The proposed revocation is based on the 
firm's history of continued noncompliance with the applicable biologics 
regulations and the license standards.

DATES: The firm may submit a written request for a hearing to the 
Dockets Management Branch by December 18, 1995, and any data and 
information justifying a hearing by January 16, 1996. Other interested 
persons may submit written comments on the proposed revocation by 
January 16, 1996.

ADDRESSES: Submit written requests for a hearing, any data and 
information justifying a hearing, and any 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), 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. 572-003) and the product license issued to 
Plascon, Inc., doing business as Anderson Plasma Center, 2507 Nichol 
Ave., Anderson, IN 46011, for the manufacture of Source Plasma.
    During preapproval and routine inspections conducted by FDA at 
Plascon, Inc., in 1989, 1991, 1992, and 1993, significant deviations 
from the applicable Federal regulations and the license standards were 
documented. Following each of these inspections, FDA provided to 
Plascon, Inc., written documentation of the deviations observed; FDA 
then requested that Plascon, Inc., indicate in writing what corrective 
action plan would be undertaken to remedy the deviations. Following the 
1992 inspection, FDA issued a warning letter dated November 12, 1992, 
to Plascon, Inc., advising the firm that failure to promptly correct 
the deviations observed during the inspection could result in 
regulatory action by FDA without further notice.
    In response to FDA's inspectional observations, in letters dated 
December 19, 1989, October 17, 1991, and January 6, 1993, Plascon, 
Inc., proposed corrective action plans. However, subsequent inspections 
of Plascon, Inc., by FDA continued to demonstrate that sufficient and 
effective long-term corrective action had not been achieved. Plascon, 
Inc.'s, cumulative inspectional history thus established a pattern of 
continued noncompliance with the applicable Federal regulations and 
license standards.
    The most recent inspection, conducted from December 13 through 
December 17, 1993, revealed continuing significant deviations from the 
applicable regulations and the license standards. These deviations 
included, but were not limited to, the following: (1) Failure to 
adequately determine donor suitability (21 CFR 606.100(b)(1) 

[[Page 57720]]
and 640.63(c)); (2) failure to investigate donor adverse reactions (21 
CFR 606.170(a)); (3) failure to perform adequate donor physical 
examinations (21 CFR 640.63(b)(3) and 640.63(c)(9)); (4) failure to 
provide suitable facilities (21 CFR 606.40(a)(1)); (5) failure to 
perform and maintain records of quality control for equipment and 
reagents (21 CFR 606.60(a), 606.160(b)(5)(i), and 606.160(b)(7)(iv)); 
and (6) failure to maintain complete and accurate records and follow 
standard operating procedures (21 CFR 606.160(b)(1)(i), 
606.160(b)(1)(ii), and 640.65(b)(3)).
    Accordingly, due to the serious nature of the deviations, which the 
Commissioner of Food and Drugs determined to constitute a danger to 
health, FDA suspended the firm's licenses by letter dated January 11, 
1994. In a letter to FDA dated January 20, 1994, Plascon, Inc., 
requested that revocation be held in abeyance and that a time extension 
be granted by which another corrective action plan would be submitted. 
By letter dated January 27, 1994, FDA granted the request for a time 
extension to submit in writing the corrective action plan. By letter 
dated January 28, 1994, Plascon, Inc., requested a second time 
extension for submission of the plan. By letter dated, February 10, 
1994, FDA granted the second time extension. By letter dated February 
21, 1994, Plascon, Inc., submitted the corrective action plan to FDA.
    After consideration of Plascon, Inc.'s, submission, FDA sent a 
letter dated May 5, 1994, denying Plascon, Inc.'s, request that the 
license revocation be held in abeyance. FDA advised Plascon, Inc., that 
the most recent corrective action plan was incomplete and inadequate, 
and that Plascon, Inc.'s, claim that sufficient corrective actions 
would be implemented and sustained was not credible in light of the 
firm's careless disregard of the applicable regulations and standards. 
In accordance with Sec. 601.5(b) (21 CFR 601.5(b)), FDA advised 
Plascon, Inc., that no additional time would be provided in which to 
demonstrate compliance with the regulations and standards before FDA 
would initiate proceedings to revoke Plascon, Inc.'s, licenses. 
Plascon, Inc., was offered the option of voluntarily requesting that 
the licenses be revoked. Plascon, Inc., was further advised that, 
should that option not be exercised, FDA would initiate proceedings to 
revoke the license by publishing in the Federal Register a notice of 
opportunity for a hearing on a proposal to revoke the licenses, 
pursuant to Sec. 12.21(b) (21 CFR 12.21(b)), as provided in 
Sec. 601.5(b). Plascon, Inc., did not respond to FDA's letter within 
the specified response period.
    Thus, under Sec. 12.21(b), FDA is issuing a notice of opportunity 
for a hearing on a proposal to revoke Plascon, Inc.'s, licenses. FDA 
has placed copies of letters between FDA and Plascon, Inc., concerned 
with the revocation on file with the Dockets Management Branch (address 
above) under the docket number found in brackets in the heading of this 
notice. These documents include the following: (1) November 12, 1992, 
warning letter from FDA to Plascon, Inc.; (2) January 6, 1993, response 
letter from Plascon, Inc., to FDA regarding FDA inspectional findings 
of inspection conducted between August 11, 1992, and October 21, 1992; 
(3) January 7, 1994, response letter from Plascon, Inc., to FDA 
regarding FDA inspectional findings of inspection conducted between 
December 13, 1993, and December 17, 1993; (4) January 11, 1994, letter 
from FDA to Plascon, Inc., suspending the firm's licenses; (5) January 
20, 1994, letter from Plascon, Inc., to FDA requesting that license 
revocation be held in abeyance and that an extension of time be granted 
to submit another corrective action plan; (6) January 27, 1994, letter 
from FDA granting the request for an extension of time to submit in 
writing a corrective action plan; (7) January 28, 1994, letter from 
Plascon, Inc., requesting a second extension of time for submission of 
a corrective action plan; (8) February 10, 1994, letter from FDA to 
Plascon, Inc., granting the second extension of time; (9) February 21, 
1994, letter from Plascon, Inc., submitting a corrective action plan to 
FDA; and (10) May 5, 1994, letter from FDA to Plascon, Inc., denying 
the firm's request that the revocation be held in abeyance and advising 
Plascon, Inc., that the corrective action plan submitted by letter 
dated February 21, 1994, was incomplete and inadequate and that FDA 
would institute license revocation proceedings. These documents are 
available for public examination in the Dockets Management Branch 
between 9 a.m. and 4 p.m., Monday through Friday.
    Plascon, Inc., may submit a written request for a hearing to the 
Dockets Management Branch by December 18, 1995, and any data and 
information justifying a hearing must be submitted by Janaury 16, 1996. 
Other interested persons may submit comments on the proposed revocation 
by January 16, 1996.
    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 a proposed revocation of a license are contained in 21 CFR 
parts 12 and 601. A request for a hearing may not rest upon mere 
allegations or denials but must 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 not genuine and 
substantial issue of fact for resolution at a hearing, or if a request 
for a hearing is not made within the specified time, or in the required 
format or the required analyses, the Commissioner of Food and Drugs 
will deny the hearing request, making findings and conclusions that 
justify the denial.
    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, Center for Biologics Evaluation and 
Research (21 CFR 5.67).

    Dated: November 8, 1995.
Kathryn C. Zoon,
Director, Center for Biologics Evaluation and Research.
[FR Doc. 95-28367 Filed 11-16-95; 8:45 am]
BILLING CODE 4160-01-F