[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
