[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]
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