[Federal Register Volume 62, Number 246 (Tuesday, December 23, 1997)]
[Notices]
[Pages 67078-67081]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33373]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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


Plascon, Inc., dba Anderson Plasma Center; Denial of Request for 
a Hearing and Revocation of 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 denying the request 
for a hearing and revokes the establishment license (U.S. license 
number 572-003) and product license issued to Plascon, Inc., doing 
business as Anderson Plasma Center, for the manufacture of Source 
Plasma. The agency finds that there is no genuine and substantial issue 
of fact justifying a hearing on the revocation of Plascon's licenses. 
The licenses are revoked due to the firm's failure to comply with the 
applicable biologics regulations and license standards designed to 
ensure the safety, purity, and potency of the manufactured products.

DATES: The revocation of the establishment license (U.S. License No. 
572-003) and product license is effective December 23, 1998.
FOR FURTHER INFORMATION CONTACT: Dano B. Murphy, Center for Biologics 
Evaluation and Research (HFM-17), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of November 17, 1995 (60 FR 57719), FDA 
announced an opportunity for a hearing on its proposal to revoke the 
establishment license (U.S. License No. 572-003) and product license 
issued to Plascon, Inc., doing business as Anderson Plasma Center, for 
the manufacture of Source Plasma (60 FR 57719). By letter dated 
December 12, 1995, Plascon requested a hearing on the proposed 
revocation. The agency is denying the request for a hearing and is 
revoking U.S. License No. 572-003, which includes the establishment 
license and product license, because the agency finds there is no 
genuine and substantial issue of fact regarding the basis for the 
proposed revocation for the firm's failure to comply with applicable 
Federal regulations and license standards. FDA has documented Plascon's 
failure to conform to such standards during inspections of Plascon in 
1989, 1991, 1992, and 1993.
    During a December 1989 inspection of Plascon, FDA investigators 
documented numerous deviations from the current good manufacturing 
practice (CGMP) regulations. The deviations included, but were not 
limited to, the following: (1) Failure to adequately determine donor 
suitability (part 606 (21 CFR part 606)) (Sec. 606.100(b)(1)) and (part 
640 (21 CFR part 640)) (Sec. 640.63(c)); (2) failure to maintain 
accurate donor records (Sec. 606.160(b)(1)); (3) failure to ensure that 
personnel were competent in the performance of their duties 
(Sec. 606.20(b)); and (4) poor record keeping practices related to 
quality control, equipment calibration, and maintenance 
(Sec. 606.160(b)(5) and (b)(7)).
    An FDA inspection of Plascon in September 1991 revealed similar 
CGMP deficiencies, as well as additional violations, including: (1) 
Failure to follow the standard operating procedures (SOP's) for 
documenting donor weight loss of 10 or more pounds or referring these 
donors to the physician on call (Sec. 606.100); (2) failure to record 
donor blood losses (Sec. 606.160(b)); (3) failure to maintain adequate 
facilities (Sec. 606.40); and (4) failure to properly maintain 
equipment (Sec. 606.60).
    During an inspection of Plascon from August through October 1992, 
FDA inspectors found CGMP deviations similar to those documented during 
the

[[Page 67079]]

previous two inspections, despite Plascon's assurances that the firm 
was in compliance with Federal regulations. The violations observed 
during this inspection included: (1) Failure to adequately investigate 
donor adverse reactions (Secs. 606.170(a), 606.100(b)(9), and 
606.160(b)(1)(iii)); (2) failure to maintain complete and accurate 
records of donors (Sec. 606.160(b)(1)); (3) failure to maintain the 
plasma at a proper storage temperature (Secs. 606.100(b)(10) and 
640.76(a)(1)); (4) failure to adequately observe, standardize, or 
calibrate equipment (Secs. 606.100(b)(15) and 606.60); (5) failure to 
maintain adequate facilities (Sec. 606.40); and (6) failure to follow 
SOP's (Sec. 606.100). FDA issued a warning letter to Plascon on 
November 12, 1992. In the warning letter, FDA stated that Plascon was 
responsible for ensuring that operations at all of its centers were in 
full compliance with the Federal Food, Drug, and Cosmetic Act (the 
act), 21 U.S.C. 301 et seq., and its implementing regulations, and 
requested that Plascon take prompt action to correct the deviations 
noted. The warning letter notified Plascon that failure to take prompt 
corrective action could result in regulatory action without further 
notice, including license suspension and/or revocation. On January 6, 
1993, Plascon sent a letter to FDA promising corrective action.
    FDA conducted another inspection of Plascon in July 1993 and 
documented continued deficiencies, including: (1) Failure to adequately 
determine donor suitability (Secs. 606.100(b)(1) and 640.63(c)); (2) 
failure to maintain adequate facilities (Sec. 606.40); and (3) failure 
to provide adequate equipment maintenance (Sec. 606.60).
    At the conclusion of each of these inspections, FDA issued to 
Plascon a list of observations from the inspection (Form FDA-483), 
which detailed Plascon's continuing noncompliance with the applicable 
regulations and license standards. After each inspection, Plascon 
promised corrective action.
    Subsequently, FDA conducted an inspection of Plascon on December 11 
through December 17, 1993, and FDA again documented numerous CGMP 
deviations. The CGMP violations observed included the following, among 
others: (1) Failure to adequately determine donor suitability 
(Secs. 606.100(b)(1) and 640.63(c)); (2) failure to investigate adverse 
donor reactions (Sec. 606.170(a)); (3) failure to perform adequate 
physical examinations on donors (Sec. 640.63(b) and (c)); (4) failure 
to perform and maintain records of quality control for equipment and 
reagents (Secs. 606.60(a), 606.160(b)(5) and (b)(7)); and (5) failure 
to maintain complete and accurate records and to follow SOP's 
(Secs. 606.160(b) and 640.65(b)(3)).
    Due to the serious nature of the deviations from the applicable 
regulations and the standards in Plascon's licenses, which the agency 
determined to constitute a danger to health, on January 11, 1994, FDA 
suspended Plascon's licenses and denied the firm's pending license 
supplements for automated collection of Source Plasma. FDA's suspension 
letter noted that the basis for the suspension was Plascon's serious 
noncompliance with donor protection standards that are designed to 
assure a continuous and healthy donor population, and the firm's 
noncompliance with standards designed to assure the continued safety, 
purity, potency, and quality of the manufactured products. (Letter from 
FDA to Plascon, January 11, 1994, at p. 4.) The suspension letter 
stated that ``[t]he nature of the deficiencies * * * leads us to 
conclude that they are a direct consequence of [Plascon's] disregard 
for the applicable regulations and standards in [Plascon's] license 
application.'' (Id.) The suspension letter notified Plascon that its 
licenses were suspended and that FDA would proceed to revoke Plascon's 
licenses unless the firm requested that revocation be held in abeyance 
pending resolution of the matters involved and provided FDA with a 
written description of the ``specific actions taken to correct all 
deficiencies noted'' in the suspension letter.
    By letter dated January 20, 1994, Plascon requested that FDA hold 
the proposed revocation of its licenses in abeyance and extend until 
January 31, 1994, the time for Plascon to prepare and submit a 
corrective action plan. On January 27, 1994, FDA granted the request 
for a time extension to submit the corrective action plan. By letter 
dated January 28, 1994, Plascon requested that FDA extend until 
February 21, 1994, the time for Plascon to submit a corrective action 
plan. On February 10, 1994, FDA granted the second-time extension 
request. By letter dated February 21, 1994, Plascon submitted its 
corrective action plan to FDA.
    After considering Plascon's corrective action plan, FDA, by letter 
dated May 5, 1994, denied the firm's request that the license 
revocation be held in abeyance. FDA explained that the
    ``current and previous inspections of [Plascon] have revealed 
continuing significant deviations from applicable regulations and 
standards specified in [Plascon's] license and establish[] a pattern 
of failure to implement appropriate and lasting corrections of these 
deviations.''
(Letter from FDA to Plascon dated May 5, 1994, at p. 1.) FDA advised 
Plascon that its corrective action plan was incomplete and inadequate 
and detailed some of the plan's inadequacies. In addition, FDA 
explained that the ``nature of the deficiencies and continued 
noncompliance * * * demonstrates careless disregard for the applicable 
regulations and the standards of [Plascon's] license.'' (Id. at p. 2.) 
FDA's letter notified Plascon that ``[i]n cases involving willfulness, 
the agency need not provide an opportunity for the licensee to 
demonstrate or achieve compliance,'' and that FDA was ``initiating 
proceedings to revoke'' Plascon's licenses. (Id.)
    Subsequently, in the Federal Register of November 17, 1995, FDA 
announced a notice of opportunity for a hearing (NOOH) on the proposed 
revocation of the establishment license and product license issued to 
Plascon. In the NOOH, FDA advised Plascon that 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 (60 FR 
57719 at 57720). The NOOH further stated that if it appeared 
conclusively from the face of the data, information, and factual 
analyses submitted in support of the request for a hearing that there 
was no genuine and substantial issue of fact for resolution at a 
hearing, the Commissioner of Food and Drugs (the Commissioner) would 
deny the hearing request (60 FR 57719 at 57720).
    In a letter dated December 12, 1995, Plascon requested a hearing on 
the proposed license revocation. On January 12, 1996, Plascon submitted 
``data and information'' in support of its request. (See Sec. 12.24 (21 
CFR 12.24).) In its letter, Plascon stated that the firm ``does not 
deny that during a series of inspections between 1989 and 1993 by FDA 
inspectors, a variety of deviations from the applicable federal 
regulations were observed.'' (Letter from Plascon to FDA, January 12, 
1996, at p. 1-2.) However, Plascon argued that FDA's determination that 
Plascon's continued operation posed a danger to health was not 
supported by an adequate factual basis. Plascon argued that a 
``reasonable and valid connection must be established between the 
deviations noted [by FDA] and the `danger to health' alleged.'' (Id. at 
p. 1.) Plascon further argued that a hearing was necessary so that the 
``largely unsupported conclusion of a public health danger can be set 
forth, explored, and tested during the course of a hearing.'' (Id.)

[[Page 67080]]

    Plascon's letter of January 12, 1996, also referred to and enclosed 
a letter that Plascon sent to FDA on June 29, 1994, regarding the 
disposition of inventory of Source Plasma on hand at Plascon when FDA 
suspended Plascon's licenses. In its June 29, 1994, letter, the firm 
stated that it did not seek to ``justify or minimize the deviations 
from regulatory requirements that were observed during the various FDA 
inspections'' (letter from Plascon to FDA, June 29, 1994, at p. 2), and 
conceded that the conditions at Plascon's facilities during the 
December 1993 inspection were ``deplorable.'' (Id. at p. 3.) 
Nevertheless, Plascon argued that ``the safety, purity, potency, and 
quality of much of the Source Plasma collected during that time period 
can indeed be assured.'' (Id. at p. 2.)

II. Applicable Regulations

    In accordance to Sec. 601.6 (21 CFR 601.6), whenever the 
Commissioner has reasonable grounds to believe that any of the grounds 
for revocation of a license exist, and that by reason thereof there is 
a danger to health, he may notify the licensee that his license is 
suspended (Sec. 601.6(a).) Upon suspension of a license, the 
Commissioner shall either: (1) Proceed in accordance to the provisions 
of Sec. 601.5(b) (21 CFR 601.5(b)) to revoke the license; or (2) if the 
licensee agrees, hold revocation in abeyance pending resolution of the 
matters involved (Sec. 601.6(b).)
    The grounds for revocation are set forth at Sec. 601.5(b). In 
accordance to Sec. 601.5(b)(4), if the Commissioner finds that the 
establishment or the product for which a license has been issued fails 
to conform to the applicable standards established in the license and 
the regulations designed to ensure the continued safety, purity, and 
potency of the manufactured product, he shall notify the licensee of 
his intention to revoke the license, setting forth the grounds for, and 
offering an opportunity for a hearing on, the proposed revocation. 
Except as provided in Sec. 601.6 or in cases involving willfulness, the 
notification of intent to revoke shall provide a reasonable period for 
the licensee to demonstrate or achieve compliance with the applicable 
requirements before proceedings will be instituted for revocation of 
the license (Sec. 601.5(b).)
    The procedures for hearings on the revocation of biologics licenses 
are set forth in part 12 (21 CFR part 12). (See Sec. 601.7.) The 
criteria for deciding whether to grant or deny a hearing are stated in 
Sec. 12.24(b). These regulations provide that 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 
(Sec. 12.24(b)(1)(2).) If it conclusively appears from the face of the 
data, information, and factual analyses in the request for a hearing 
that there is no genuine and substantial issue of fact that requires a 
hearing on the revocation of the license, the Commissioner will deny 
the hearing request and enter summary judgment against the licensee. 
(Sec. 12.24(b)(1); see also Costle v. Pacific Legal Found., 445 U.S. 
198, 214-15 (1980); Weinberger v. Hynson, Westcott & Dunning, Inc., 412 
U.S. 609, 620-21 (1973).) Moreover, where the issues raised in the 
hearing request are, even if true, legally insufficient to alter the 
decision, the Commissioner need not grant a hearing. (Sec. 12.24(b)(4) 
(hearing request will not be granted ``if the Commissioner concludes 
that the action would be the same even if the factual issue were 
resolved in the way sought'').) Therefore, to warrant a hearing, 
Plascon must set forth a genuine and substantial issue of fact 
concerning the grounds for revocation of its licenses.

III. Plascon's Hearing Request and the Commissioner's Findings

    Plascon's challenge to the proposed revocation of its establishment 
and product licenses is a narrow one. Plascon's hearing request and the 
data and information the firm submitted in support of its hearing 
request do not challenge whether Plascon failed to comply with 
applicable regulations and the standards set forth in the firm's 
licenses; instead, Plascon only disputes whether Plascon's deviations 
from FDA's regulations constitute a ``danger to health.'' (See, e.g., 
Letter from Plascon to FDA, January 12, 1996, p. 3 (``The fact that 
there were deviations from regulatory requirements * * * does not 
automatically establish that a `danger to health' was present. Danger 
to who? The employees? The donors? * * * These are factual issues that 
require exploration at the requested hearing * * *'').) For the reasons 
set forth below, the agency finds that there is no genuine and 
substantial issue of fact justifying a hearing and therefore denies 
Plascon's request for a hearing.
    Before proceeding to the basis for Plascon's request for a hearing, 
the agency notes that FDA's decision to initiate revocation proceedings 
without providing Plascon with a further opportunity to demonstrate or 
achieve compliance was appropriate. As noted above, FDA's regulations 
provide:

    Except as provided in [21 CFR] 601.6 or in cases involving 
willfulness, the notification [of intent to revoke] shall provide a 
reasonable period for the licensee to demonstrate or achieve 
compliance with the requirements of this chapter, before proceedings 
will be instituted for revocation of the license.
(Sec. 601.5(b).)

    After FDA suspended Plascon's licenses in January 1994, in response 
to Plascon's request, FDA held revocation of the firm's licenses in 
abeyance pending resolution of the matters involved. (See 
Sec. 601.6(b).) FDA's January 11, 1994, suspension letter notified 
Plascon that FDA would proceed with revocation unless, inter alia, the 
firm notified FDA in writing of the:

    specific actions taken to correct all deficiencies noted in this 
letter including a detailed explanation of all retraining of all 
personnel as well as the means by which such training is to be 
evaluated.
(Letter from FDA to Plascon, January 11, 1994, at p. 6.)

    FDA granted both of the extensions that Plascon requested for 
submission of a corrective action plan. Subsequently, after considering 
Plascon's February 21, 1994, submission, FDA advised Plascon by letter 
that the firm's corrective action plan was incomplete and inadequate 
and that the firm'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 this 
letter, FDA also notified Plascon that it no longer would hold the 
license revocation in abeyance and that the agency would initiate 
revocation proceedings. (Letter from FDA to Plascon, May 5, 1994, at p. 
2.) Citing the May 5, 1994, letter, the November 17, 1995, NOOH also 
noted Plascon's ``careless disregard of the applicable regulations and 
standards'' and stated that FDA had advised Plascon ``that no 
additional time would be provided in which to demonstrate compliance'' 
before FDA would initiate revocation proceedings (60 FR 57710 at 
57720).
    The agency notes that Plascon's hearing request and the data and 
information it submitted in accordance to that request do not challenge 
the May 5, 1994, letter's assertion that Plascon had acted in careless 
disregard of the applicable regulations and standards. Similarly, the 
firm has not objected to FDA's decision to institute revocation 
proceedings without providing Plascon further opportunity to 
demonstrate or achieve compliance. (Letter from Plascon to FDA, 
December 12, 1995; Letter from Plascon to FDA, January 12, 1996.)

[[Page 67081]]

    While the Commissioner does not need to reach the issue of whether 
FDA's decision not to provide further opportunity to demonstrate or 
achieve compliance was proper under Sec. 601.5, he notes that 
Sec. 601.5 requirements have been satisfied because Plascon's conduct 
was willful within the meaning of Sec. 601.5. Courts that have 
considered the meaning of willfulness in the context of license 
revocation proceedings have noted that willful conduct can be found 
when a person acts with careless disregard of statutory requirements. 
(See, e.g., Potato Sales Co., Inc. v. United States Dept. of Agric., 92 
F.3d 800, 805 (9th Cir. 1996); Cox v. United States Dept. of Agric., 
925 F.2d 1102, 1105 (8th Cir. 1991), cert. denied, 502 U.S. 860 (1991); 
Lawrence v. Commodity Futures Trading Corp., 759 F.2d 767, 773 (9th 
Cir. 1985); Finer Food Sales Co. v. Block, 708 F.2d 774, 778 (D.C. Cir. 
1983); American Fruit Purveyors Inc. v. United States, 630 F.2d 370, 
374 (5th Cir. 1980), cert. denied, 450 U.S. 997 (1981).) Plascon's 
pattern of continued noncompliance with the applicable license 
standards and regulations, despite ample notice from the FDA of the 
firm's noncompliance and repeated assurances from Plascon that the firm 
would come into compliance, demonstrates careless disregard of the 
applicable requirements. Thus, the agency finds that Plascon's conduct 
was willful within the meaning of Sec. 601.5, and thus it was not 
necessary to provide Plascon with further opportunity to demonstrate or 
achieve compliance.
    The next issue for consideration is whether the data and 
information Plascon submitted raise a genuine and substantial issue of 
fact for resolution at a hearing (Sec. 12.24(b)(1).) FDA's proposed 
revocation of Plascon's establishment and product licenses is based on 
Plascon's failure to adhere to the applicable regulations and the 
standards in Plascon's license application, not on a finding that these 
failures constitute a ``danger to health.'' (Letter from FDA to 
Plascon, May 5, 1994, at p. 1-3; 60 FR 57719.) FDA's focus on Plascon's 
failure to comply with the applicable regulations and standards 
conforms to the applicable regulations. (See Sec. 601.5(b)(4).)
    The grounds for revocation set forth in Sec. 601.5(b)(4) have been 
established in this case. As described above, FDA's inspections 
documented Plascon's deviations from the applicable regulations and 
standards during four inspections between 1989 and 1993. Plascon has 
not only failed to submit any data and information challenging FDA's 
inspectional findings, but also has admitted that the firm failed to 
comply with the applicable regulations. Indeed, by the firm's own 
characterization, the conditions observed during the 1993 inspection, 
which led to the suspension and proposed revocation of Plascon's 
licenses, were ``deplorable.'' (See Letter from Plascon to FDA, June 
29, 1994, at p. 3 (``[I]t is a source of great regret'' that the:
    conditions observed by FDA investigators * * * during the[] 
December 13-17, 1993 inspection of [Plascon] were so deplorable, 
resulting in the issuance of a Form FDA-483 with 66 inspectional 
observations * * * [T]he facility was not operating in an acceptable 
manner, and [Plascon] accepts full responsibility for that extremely 
unfortunate situation.);
see also id. at p. 2 (``Without for a moment seeking to justify or 
minimize the deviations from regulatory requirements that were observed 
during the various FDA inspections over the more than four year period 
of time * * *''); id. at p. 25 (``The final inspection, in December of 
1993, was by far the `worst' of these inspections * * *''); id. at 28 
(``if the December 1993 inspection had been a completely successful 
one, instead of the disaster that it obviously was * * *''); Letter 
from Plascon to FDA dated February 21, 1994, Corrective Action Plan, at 
p. 2 (``Plascon, Inc. has terminated employees who were not following 
proper protocol during the most recent FDA inspection.'').)
    Having conceded the existence of the ``deplorable'' conditions at 
Plascon, the firm confines its challenge to the proposed revocation of 
its licenses to whether FDA established the existence of a danger to 
health when the agency suspended Plascon's licenses on May 5, 1994. 
More specifically, Plascon argues that the regulatory deficiencies 
observed did not affect the quality of the Source Plasma manufactured 
by the firm and that FDA has not established the existence of a 
``danger to health.'' (Letter from Plascon to FDA dated January 12, 
1996, at p. 1.) However, while the issue of whether the Commissioner 
had reasonable grounds to believe that by reason of the existence of 
the grounds for revocation of Plascon's licenses there was ``a danger 
to health'' was relevant to the decision to suspend the firm's 
licenses, it has no bearing on the revocation of those licenses under 
Sec. 601.5(b).
    Plascon's hearing request will be granted only if the material 
submitted shows that there is a genuine and substantial issue of fact 
for resolution at a hearing (Sec. 12.24(b)(1)). A hearing will not be 
granted on factual issues that are not determinative with respect to 
the action requested (Sec. 12.24(b)(4)). As the District of Columbia 
Circuit Court of Appeals observed, ``Only disputes over facts that 
might affect the outcome of the suit under the governing law will 
properly preclude the entry of summary judgment. Factual disputes that 
are irrelevant or unnecessary will not be counted.'' Copanos & Sons v. 
FDA, 854 F.2d 510, 523 (D.C. Cir. 1988). Plascon's hearing request 
raises only an irrelevant factual dispute, the resolution of which, 
even if in Plascon's favor, would have no bearing on the merits of the 
revocation of its licenses.
    For the reasons set forth above, the agency finds that Plascon, 
Inc., doing business as Anderson Plasma Center, has failed to show that 
there is a genuine and substantial issue of fact justifying a hearing 
on the revocation of its establishment and product licenses. The agency 
also finds that significant deviations from the biologics regulations 
and the standards set forth in the firm's licenses existed which 
warrant revocation of Plascon's licenses. Therefore, under section 351 
of the Public Health Service Act (42 U.S.C. 262) and under Secs.  
12.28, 601.5, and 601.7, the Commissioner denies the request for a 
hearing and revokes the establishment (U.S. License No. 572-003) and 
product licenses issued to Plascon, Inc., doing business as Anderson 
Plasma Center, for the manufacture of Source Plasma.

    Dated: December 16, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-33373 Filed 12-22-97; 8:45 am]
BILLING CODE 4160-01-F