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

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