CHRISTOPHER J. CHRISTIE
United States Attorney
By: PETER W. GAETA
Assistant United States Attorney
970 Broad Street, Suite 700
Newark, New Jersey 07102
(973) 645-2927
JOEL SCHWARTZ
Trial Attorney
Office of Consumer Litigation
U.S. Department of Justice
P.O. Box 386
Washington, D.C. 20044
(202) 514-0514
ERIC M. BLUMBERG
Special Assistant
United States Attorney
U.S. Food and Drug Administration
5600 Fishers Lane, Room
6-13
Rockville, MD 20857
(301) 827-1138
UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY
UNITED STATES OF AMERICA,
Plaintiff,
UNDETERMINED QUANTITIES
OF BOXES OF ARTICLES OF
DEVICE
* * *
and
SHELHIGH, INC.,
and SHLOMO GABBAY, M.D.,
and LEA
GABBAY, individuals
Defendants. |
Hon. William J. Martini
Civil Action No.
07 CV 1769 WJM
|
CONSENT ORDER
On April 16,2007, plaintiff, the United
States of America, by and through its attorneys,
filed a verified Complaint for Forfeiture In Rem (Complaint)
against articles of device in the
possession of Shelhigh, Inc. (Shelhigh), a business
entity that was incorporated under the laws of New
Jersey but is doing business as "Shelhigh, Inc.," located
at 650 Liberty Avenue, Union, New Jersey. The Complaint
alleges that the defendant articles of device are adulterated
within the meaning of the Federal Food, Drug, and Cosmetic
Act ("Act"), 21 U.S.C. § 351(h),
because the methods used in, and the facilities and
controls used for, their manufacture, packing, storage,
and installation are not in conformity with current
good manufacturing practice (CGMP) requirements for
devices as set forth in the Quality System (QS) regulation,
21 C.F.R. Part 820.
Pursuant to a Warrant for Arrest In Rem issued by this
Court, the United States Marshal for this district
seized the defendant articles on April 17,2007. On
April 24,2007, Shelhigh intervened and filed a claim
to the seized articles. Shelhigh filed an Answer to
the Complaint on May 14,2007.
Claimant Shelhigh and Defendants Shelhigh, Shlomo Gabbay,
M.D., and Lea Gabbay (hereafter, collectively, defendants)
having appeared and voluntarily consented to the entry
of this Order without contest, before any testimony
has been taken, without admitting the violations alleged
in the Complaint, and waiving the filing and service
of an amended complaint seeking injunctive relief,
and the United States having consented to this Order:
IT IS HEREBY ORDERED, ADJUDGED, AND DECREED THAT:
- This Court has subject matter jurisdiction over
this action and personal jurisdiction over all parties
pursuant to 28 U.S.C. §§ 1331, 1337, and
1345 and 21 U.S.C. §§ 332 and 334. Venue
is proper in this district under 21 U.S.C. § 1391(b)
and (c).
- The Complaint states a claim for relief against
defendants under the Act, 21 U.S.C.
§§ 301-397.
- Defendant Shelhigh affirms that it is
the sole owner of the seized articles, and that no other
person has an interest in the seized articles. Defendant
Shelhigh further affirms that it shall indemnify and hold
the United States harmless should any other party or parties
hereafter file or seek to file a statement of interest
or right to intervene in this action, or seek to defend
or obtain any part of the seized articles.
SECTION 334 PROVISIONS
- The seized articles are devices that are in violation
of 21 U.S.C. § 351(h).
- The seized articles are hereby condemned pursuant to
21 U.S.C. § 334 and forfeited to the United
States.
- Pursuant to 21 U.S.C. § 334(e), Shelhigh
shall pay to the United States all court costs and fees,
storage and other proper expenses of this proceeding incurred
to date, and such additional expenses as may hereinafter
be incurred and taxed. Defendant Shelhigh shall pay these
costs within ten (10) days of receiving written notice
from the United States of such costs.
- Pursuant to 21 U.S.C. § 334(d)(1), within
three hundred and sixty (360) days of the entry of this
Order, Shelhigh shall execute and file with the Clerk of
this Court a good and sufficient penal bond with surety
in the amount of one and one half million dollars ($1,500,000.00)
in a form acceptable to the Clerk of this Court and payable
to the United States of America, and conditioned on Shelhigh's
abiding by and performing all of the terms and conditions
of this Order and of such further orders and decrees as
may be entered in this proceeding.
The penal bond shall be applied initially to all components
that have not been sterilized ("Phase I" articles)
and subsequently and sequentially applied to succeeding
lots as described in subparagraphs A-D of this paragraph.
However, at no time may Shelhigh have seized articles
released to it articles whose total retail value exceeds
one million dollars ($1,000,000.00). The schedule for
release of the devices and components is as follows:
- The Phase I articles, which will be further designated
by the FDA representative and which are stored at
the Shelhigh facility located at 650 Liberty Avenue,
Union, New Jersey 07083, shall be released to Shelhigh
for the sole purpose of attempting to bring the Phase
I articles into compliance with the law up to but
not including the sterilization and subsequent manufacturing
steps.
- If, and only if, Shelhigh complies with all of
the terms of this Order with respect to the Phase
I articles, and Phase I articles have been released
in writing by FDA for sterilization and subsequent
processing (i.e., conversion to "Phase II" articles),
a portion of the Phase I seized articles with a total
value not to exceed one million dollars ($1,000,000.00)
retail shall be designated by the FDA representative
for re-release to Shelhigh for the purpose of attempting
to bring said articles into compliance with the law.
- If, and only if, Shelhigh complies with all of
the terms of this Order with respect to the release
of the articles in subparagraph A and B of this paragraph,
and those articles have been released in writing
by FDA for distribution, additional Phase II seized
articles with a total value not to exceed one million
dollars ($1,000,000.00) retail shall be further designated
by the FDA representative for release to Shelhigh
for the purpose of attempting to bring said articles
into compliance with the law.
- The tenns of subparagraphs B and C of this paragraph
shall apply to the sequential release of seized articles,
each consisting of a lot whose value does not exceed
one million dollars ($1,000,000.00) retail.
- Shelhigh may at any time, with prior notice and
written consent of an FDA representative, increase
the value of penal bond to obtain a greater amount
of seized articles for attempted reconditioning.
- After filing the bond with this Court pursuant to paragraph
7 of this Order, Shelhigh shall give written notice to
the United States Food and Drug Administration (FDA) at
the addresses specified in paragraph 30 of this Order that
Shelhigh, at its own expense, is prepared to attempt to
bring the seized articles into compliance with the law
under the supervision of a duly authorized representative
of FDA.
- Shelhigh shall submit to FDA a detailed written plan
describing its proposal to attempt to bring the seized
articles into compliance with the law ("reconditioning
plan"). Shelhigh shall not attempt to bring the seized
articles into compliance until it has submitted to FDA
a reconditioning plan (with accompanying protocols, validation
data, expert reports, and standard operating procedures
(SOPs)) as FDA deems necessary and FDA has provided Shelhigh
with written authorization to commence reconditioning.
The reconditioning plan may be done in stages acceptable
to FDA; defendants shall consult with FDA before developing
and submitting a reconditioning plan. FDA's decision regarding
the adequacy of the reconditioning plan shall be final.
The reconditioning plan described in this paragraph shall
also be applicable to any components and finished devices
manufactured or returned to Shelhigh between April 17,2007
and the date on which this Order is entered.
- FDA shall notify Shelhigh in writing within thirty (30)
business days of FDA's receipt of each Shelhigh reconditioning
plan whether the proposed reconditioning plan is acceptable
and provides a potential opportunity to recondition the
goods. Shelhigh understands that FDA makes no assurance
that the attempted reconditioning will be successful.
- Following the payment of costs and posting of the bond
by Shelhigh, as required by paragraphs 6 and 7 of this
Order, and following Shelhigh's receipt of written authorization
to commence attempted reconditioning, as described in paragraph
9 of this Order, the United States Marshal for this district
shall, upon receiving notice from FDA, release the seized
articles to the custody of Shelhigh for the sole purpose
of attempting to bring the articles into compliance with
the law pursuant to the reconditioning plan described in
paragraph 9.
- Shelhigh shall not, directly or indirectly, cause the
seized articles or any part thereof to be shipped, sold,
or disposed of in a manner contrary to the provisions of
the Act, any other federal law, or the laws of any State
or Territory (as defined in the Act) in which the articles
are shipped, sold, or disposed. All seized articles that
are not brought into compliance under a reconditioning
plan accepted in writing by FDA pursuant to paragraph 9
shall be destroyed at Shelhigh's expense under the supervision
of an FDA representative, and Shelhigh shall pay to the
United States all costs incurred in supervising the destruction
of such articles, at rates specified in paragraph 27 of
this Order.
- Shelhigh shall at all times, until the seized articles
have been released in writing by an FDA representative
for shipment, sale, or other disposition, retain the seized
articles intact for examination or inspection by FDA at
the Shelhigh facility located at 650 Liberty Avenue, Union
NJ 07083, and shall retain all records or other proof necessary
to establish the identity of the seized articles to the
satisfaction of an FDA representative.
- Shelhigh shall at no time and under no circumstances,
directly or indirectly, cause or permit the shipment, sale,
or other disposal of the seized articles, or any part thereof,
unless and until an FDA representative has had free access
to the articles to take any samples or make any examinations
that are deemed necessary, and an FDA representative has
released, in writing, such seized articles for shipment,
sale, or other disposition.
- If requested by an FDA representative, Shelhigh shall
furnish duplicate copies of invoices of sale of the released
articles, or other evidence of disposition as requested
by an FDA representative.
- Within one hundred and fifty (150) days of the United
States Marshal's release of the seized articles to the
custody of Shelhigh for reconditioning pursuant to paragraph
11, or such further time as FDA may allow, Shelhigh shall
complete its attempt to bring the seized articles into
compliance with the law under the supervision of an FDA
representative and in a manner acceptable to FDA. Within
ten (10) days after this one hundred and fifty (150) day
period, Shelhigh shall destroy, at its sole expense and
under the supervision of an FDA representative, any seized
article that has not been brought into compliance within
such one hundred and fifty (150) day period.
- The United States Attorney for this district, upon being
advised by FDA that the seized articles have been brought
into compliance with the law and the requirements of this
Order or destroyed in compliance with this Order and the
law, and that Shelhigh has paid all costs to date, will
transmit such information to the Clerk of this Court, whereupon
the penal bond given in this proceeding shall be canceled
and discharged.
- If, within sixty (60) days of filing the bond pursuant
to ¶ 7, Shelhigh does not
submit a reconditioning plan as set forth in paragraph
9 of this Decree, the United States Marshal for this district
shall destroy the seized articles and make due return to
this Court regarding their disposition. Shelhigh shall
bear the costs of such destruction.
- If Shelhigh fails to abide by and perform all of the
terms and conditions of this Order or of the bond posted
in this proceeding, then that bond shall, on motion of
the United States in this proceeding, be forfeited in its
entirety and judgment entered in favor of the United States.
In addition, if Shelhigh breaches any term or condition
of this Order, then Shelhigh shall, at its own expense,
immediately retum the seized articles to the United States
Marshal for this district or otherwise dispose of them
pursuant to an order of this Court. In the event that return
of the articles becomes necessary pursuant to this paragraph,
Shelhigh shall be responsible for all costs of storage
and disposition that are incurred by the United States.
- Upon entry of this Order, defendants
and each of their officers, directors, agents, employees,
representatives, attorneys, successors, and assigns, and
any and all persons in active concert or participation
with any of them who have received actual notice of this
Order by personal service or otherwise are, except as provided
in paragraph 21 below, permanently enjoined frommanufacturing,
processing, packing, labeling, and distributing any seized
device or component or any component or device received
or processed by defendants after seizure, unless and until:
- Defendants' methods, facilities, and controls
used to manufacture, process, pack, label, and distribute
devices are established, operated, and administered
in compliance with the requirements of CGMP and the
QS regulation, 21 C.F.R. Part 820, the Medical Device
Reporting (MDR) requirements set forth at 21C.F.R.
Part 803, and this Order, including, but not limited
to, the following:
- Establishing and implementing adequate written
procedures for finished device acceptance to ensure
that each production run, lot, or batch of finished
devices meets acceptance
criteria;
- Establishing and implementing adequate written
procedures to control product that does not conform
to specified requirements;
- Establishing and implementing adequate quality
requirements that must be met by contractors, suppliers,
and consultants, and adequate written procedures
to ensure that all purchased or otherwise received
products and services conform to specified requirements;
- Developing, conducting, controlling, and monitoring
production processes to ensure that devices conform
to their specifications;
- Adequately validating processes whose results
cannot be fully verified by subsequent inspection
and testing, and establishing and implementing
adequate written procedures for monitoring and
controlling process parameters for validated processes
to ensure that specified requirements continue
to be met;
- Establishing and implementing adequate
written procedures to prevent contamination of
equipment or product by substances that could reasonably
be expected to have an adverse effect on product
quality;
- Establishing and implementing adequate written
procedures to control environmental conditions
that could reasonably be expected to have an adverse
effect on product quality;
- Establishing and
implementing adequate requirements for the health,
cleanliness, personal practices, and clothing of
personnel;
- Establishing and implementing adequate written
procedures for identifying, documenting, validating
or, when appropriate, verifying, reviewing, and
approving design changes prior to their implementation;
- Establishing and implementing adequate design
validation requirements to ensure that devices
conform to defined user needs and intended uses;
- Establishing and implementing adequate written
procedures for identifying employee training needs,
for ensuring that all personnel are trained to
adequately perform their assigned responsibilities,
and for documenting such training;
- Establishing and implementing procedures for
corrective and preventive actions (CAPA);
- Maintaining
complaint files and establishing and implementing
adequate written procedures for receiving, reviewing,
and evaluating complaints; and
- With respect
to any components and finished devices manufactured
or returned to Shelhigh between April 17, 2007
and the date on which this Order is entered, satisfactory
completion of the reconditioning plan described
in paragraph 9.
- Defendants have corrected all of the items
listed in FDA's December 20,2006 List of Observations
(FDA-483).
- Defendants develop and implement adequate written
MDR procedures in compliance with 21 C.F.R. Part
803, and ensure that employees are trained on and
understand MDR requirements.
- Defendants select and retain, at defendants'
expense, independent persons (the "experts"),
who are qualified by education, training, and experience
in the CGMP/QS regulation, microbiology, aseptic
processing of medical devices, and the MDR reporting
requirements to evaluate whether defendants are
in compliance with CGMP/QSregulation requirements
as set forth at 21 C.F.R. Part 820, the MDR reporting
requirements set forth at 21 C.F.R. Part 803, and
this Order. The expert(s) shall be without personal
of financial ties (other than the consulting agreement
between the parties) to any officer or employee
of defendants or their immediate families. Defendants
shall notify FDA in writing of the identity of
the experts as soon as they retain such experts,
and each expert shall:
- Inspect defendants' facilities, validation
protocols, validation data, processes, controls,
SOPs, and employee qualifications and training,
and training records;
- Determine whether defendants are in compliance
with the CGMP/QS regulation requirements as
set forth at 21 C.F.R. Part 820, the MDRrequirements
set forth at 21 C.F.R. Part 803, and this Order;
and
- Provide FDA with complete and detailed
written report identifying in detail which
processes, controls, SOPs,and FDA-483 observations
they inspected and their detailed evaluations
as to whether each such SOPs, systems, and
observations have been corrected and whether,
in their professional opinions, defendants
are in compliance with CGMPand 21 C.F.R. Parts
820, the MDR requirements set forth at 21 C.F.R
Part 803, and this Order.
- Defendants submit a detailed written report of
all corrections defendants have made to come in to
compliance with the requirements of the Act and 21
C.F.R. Parts 820, the MDR requirements set forth at
21 C.F.R. Part 803, and this Order. The written report
shall document what steps they have taken to: correct
each of the observations listed on FDA's December 20,
2006 List of Observations (FDA-483), to ensure that
defendants' employees and managers are adequately trained
in the CGMP/QS regulation and MDR requirements applicable
to their assigned responsibilities and positions, and
to ensure that defendants will continuously remain
in compliance with this Order.
- The experts have certified to FDA in writing that
defendants are in compliance with the Act, 21 C.F.R.
Part 820, the MDR requirements set forth at 21 C.F.R.
Part 803, and this
Order.
- Duly authorized FDA representativeshave made inspections,
as and when FDA
deems necessary and without prior notice, of defendants'
facilities, including buildings, equipment, personnel,
finished and unfinished materials, containers and labeling,
and all records relating to the manufacture, packing,
labeling, and distribution of devices to determine whether
the requirements of paragraph 20 A through F of this
Order have been met. Such inspection shall commence no
later than twenty (20) days after receipt of the reports
and certifications that meet the requirements of paragraph
20 A through F above; and
- FDA notifies defendants in writing that they appear
to be in compliance with the Act 21 C.F.R. Parts 820,
the MDR requirements set forth at 21 C.F.R. Part 803,
and this Order, and may commence manufacturing, packing,
labeling, and distributing medical devices. FDA shall
notify defendants within thirty (30) days following the
conclusion of this inspection whether defendants may
resume manufacturing, packing, labeling, and distributing
medical devices.
- Notwithstanding the prohibition in the preceding
paragraph, defendants may, at their own risk and with
the understanding that any products manufactured pursuant
to this paragraph, including components and devices that
have been satisfactorily reconditioned pursuant to paragraph
9, may not later be approved by FDA for distribution,
resume manufacturing -but not distributing for any purpose
-components and devices, under the following conditions:
- For all components and devices that have been
processed up to but not including the sterilization
step, defendants may resume manufacturing after all
of the following conditions have been met:
- defendants' experts have complied
with paragraphs 20 B and D -F for all CGMP requirements
that may affect components and processes prior
to sterilization;
- defendants have complied with paragraph 20
E and have submitted to FDA all test protocols,
validation data, validation reports, and SOPs that
FDA deems necessary to substantiate the foregoing
CGMP requirements; and
- FDA has reviewed the test
protocols, validation data, validation reports,
SOPs, and defendants' assurances and has authorized
in writing the resumption of manufacture of components
and devices up to but not including sterilization
(hereafter, collectively, "Phase
I").
- For all components and devices that have been
sterilized and completed any manufacturing step
subsequent to Phase I, defendants may resume manufacturing
after all of the following conditions have been
met:
- defendants have satisfactorily completed
all requirements of Phase I;
- defendants' experts have complied with paragraphs
20 A-F for all CGMP requirements that may affect
the sterilization of components and all steps subsequent
to sterilization;
- defendants have complied
with paragraph 20 E and have submitted
to FDA all test protocols, validation data,
validation reports, SOPs and other data
that FDA deems necessary to substantiate
the foregoing CGMP requirements; and
- FDA has reviewed the test protocols, validation
data, validation reports, expert reports, SOPs, and
defendants' assurances and has authorized in writing
the resumption of manufacture of components and devices
for the sterilization step and all subsequent manufacturing
steps (hereafter, collectively, "Phase II").
- Upon receipt of any data package described
in paragraph 21, FDA will provide defendants with
its written evaluations within thirty (30) business
days, and will exercise its best efforts to do
so sooner.
- No Phase I components or devices may be sterilized
(i.e, begin Phase II) until FDA, if
it elects to do so, has inspected defendants' facility
and Phase I processes and has advised defendants in
writing that Phase I appears to be in compliance with
the Act, 21 C.F.R. Part 820, and this Order. No Phase II products
may be released for distribution under this paragraph
until FDA has inspected defendants' facility, if it
elects to do so, and advised defendants in writing
that defendants' facilities and processes are in compliance
with the requirements of the Act and 21 C.F.R. Part
820, the MDR requirements set forth at 21 C.F.R. Part
803, and this Order.
- If it elects to do so, FDA will
initiate the inspections described in this paragraph
within ten (10) days after FDA, as provided in subparagraph
C of this paragraph, approves the data submitted by
defendants pursuant to subparagraphs A and B of this
paragraph, and will exercise its best efforts to do
so sooner. FDA will advise defendants of the results
of its inspections within twenty (20) days after completing
its inspections, and will exercise its best efforts
to do so sooner.
- After defendants resume manufacturing, packing,
labeling, and distributing devices pursuant to paragraph
20 or 21 above, defendants and each of their directors,
officers, agents, representatives, employees, attorneys,
successors, and assigns, and any and all persons in active
concert or participation with any of them who have received
actual notice of this Order by personal service or otherwise,
are permanently restrained and enjoined from directly
or indirectly doing or causing to be done any act that:
- violates 21 U.S.C. § 33 1(a), by introducing
or causing to be introduced, or delivering or causing
to be delivered for introduction, into interstate commerce
any article of device, within the meaning of 21 U.S.C. § 321(h),
that is adulterated within the meaning of 21 U.S.C. § 351(h),
or that is misbranded within the meaning of 21 U.S.C. § 352(t)(2);
- violates 21 U.S.C. § 331(k), by causing
any article of device to become adulterated within
the meaning of 21 U.S.C. § 35 1(h) or
misbranded within the meaning of 352(t)(2), while such
article is held for sale after shipment of one or more
of its components in interstate commerce; and
- violates 21 U.S.C. section 382(g), by failing to
provide the notifications set forth in that section.
- If, at any time after entry of this Order, FDA determines,
based on the results of an inspection, a sample analysis,
a report or data prepared or submitted pursuant to
this Order, or any other information, that defendants have
failed to comply with any provision of this Order,
or have violated the Act or any applicable regulation,
or that additional corrective actions are necessary to
achieve compliance with this Order, the Act, or any applicable
regulation, FDA may, as and when it deems necessary,
order defendants in writing to take appropriate action,
including, but not limited to, ordering defendants
immediately to take one or more of the following actions:
- Cease manufacturing, packing, labeling, and distributing
devices (including components);
- Revise, modify, or expand any reports or plans
prepared pursuant to this Decree;
- Submit additional reports or information to FDA;
- Recall devices released or distributed by defendants
or under the custody and control of defendants' agents,
distributors, customers, or consumers. Defendants shall
bear the costs of any such recalls; or
- Take any other corrective actions as FDA, in its
discretion, deems necessary to protect the public health
or bring defendants into compliance with the Act, the
applicable regulations, and the terms of this Order.
- Any decision issued by FDA pursuant to paragraph
23 shall specify the alleged violations giving rise
to the order. Within seven (7) days after receiving such
decision from FDA during the term of this Order, the
defendants shall notify FDA in writing that:
- The defendants are undertaking or have undertaken
the requested action(s), in which event the defendants
shall also describe the action taken or to be taken
and specify the time frame in which the action
will be completed; or
- The defendants disagree with FDA's decision,
in which case the defendants shall state in writing
the reasons for the disagreement. In so doing,
the defendants may propose specific alternative
actions and specific time frames for achieving
FDA's objectives.
- If the defendants notify FDA that they do not
agree with FDA's decision, FDA will review the
defendants' objections, and thereafter, in writing,
affirm, modify, or withdraw its decision, as FDA
deems appropriate;
- If FDA affirms or modifies its decision, defendants
shall, within ten (10) business days of receipt
of the decision, begin to implement the decision
(as modified, if applicable) and, if they so choose,
bring the matter before this Court for review.
Defendants shall continue to diligently implement
FDA's decision unless and until the Court reverses
or modifies FDA's order. Any review of FDA's decision
under this paragraph shall be made in accordance
with the terms set forth in paragraph 33; and
- Any cessation of operations or other action
described in paragraph 23 shall continue until
defendants receive written notice from FDA that
defendants appear to be in compliance with this
Order, the Act, and its implementing regulations.
All costs of recall(s) and corrective actions ordered
by FDA pursuant to paragraph 23 shall be bome by
the defendants. The costs of FDA inspections, sampling,
testing, document preparation and review time,
travel time, and subsistence expenses to implement
the remedies set forth in this paragraph shall
be bome by the defendants at the rates specified
in paragraph 27. This provision shall be separate
and apart from, and in addition to, all other remedies
available to FDA.
- After defendants resume manufacturing pursuant
to paragraph 20 or 21 above, they shall retain
independent experts ("auditors") who
shall meet the criteria set forth in paragraph
20 D above to conduct audits of their manufacturing
operations no less frequently than once every year.
The auditors may be the same persons retained as
experts pursuant to paragraph 20 D above.
- At the conclusion of each audit inspection,
the auditors shall prepare written reports
("audit reports")
evaluating whether defendants are in compliance
with requirements of the Act and 21 C.F.R.
Part 820, the MDR requirements set forth at
21 C.F.R. Part 803, and this Order. As part
of every audit report, the auditors shall assess
whether defendants have adequately corrected
observations made by auditors in previous reports
and any observations that FDA may have made
in an FDA-483 or written correspondence. The
audit reports shall be delivered contemporaneously
to defendants and to FDA no later than ten
(10) days after conclusion of the audits. Defendants
shall also retain the audit reports in separate
files at their facility and shall immediately
make them available to FDA investigators upon
request.
- If an audit report contains any observation
indicating that defendants are not in compliance
with requirements of the Act and 21 C.F.R.
Parts 820, the MDR requirements set forth at
21 C.F.R. Part 803, and this Order, defendants
shall correct the observation(s) within thirty
(30) days of receipt of the audit report, unless
FDA and defendants agree in writing on a different
time frame. The auditors shall review defendants'
corrections within sixty (60) days of the issuance
of the audit report and within ten (10) days
of said review shall notify defendants and
FDA in writing whether, in the auditor's opinion,
the observation has been corrected.
- Representatives of FDA shall be permitted, without
prior notice and as and when FDA deems necessary,
to inspect defendants' facilities and take any other measures
necessary to monitor and ensure continuing
compliance with the terms of this Order. During such inspections,
FDA investigators shall be permitted to make
inspections of all of Shelhigh's equipment, finished and
unfinished materials and products, containers, and labeling;
to take photographs; to collect samples of any articles
of device; and to examine and copy all records
relating to the manufacture, packing, labeling, and distribution
of any Shelhigh medical device. Such inspections
shall be authorized upon presentation of a copy of this
Order and appropriate credentials. The inspection authority
granted by this Order is apart from, and in
addition to, the authority to make inspections under the
Act, 21 U.S.C. § 374.
- Defendants shall reimburse the United States for
the costs of supervising its compliance with the terms
of this Order, including all inspections, examinations,
reviews, evaluations, analyses (and the supervision
of any of the foregoing) conducted pursuant to this
Order, at the standard rates prevailing at the time
the activities are accomplished. As of the date this
Order is signed by the parties, these rates are: $78.09
per hour and fraction thereof per representative for
inspection work; $93.61 per hour or fraction thereof
per representative for analytical work; $0.445 per
mile for travel expenses by automobile; the government
rate or equivalent for travel by air or other means;
and the published government per diem rate or the equivalent
for the areas in which the inspections are performed
per day, per representative for subsistence expenses,
where necessary. In the event that the standard rates
generally applicable to FDA supervision of court-ordered
compliance are modified, these rates shall be increased
or decreased without further order of the Court.
- Within ten (10) calendar days after entry of this
Order, defendants shall provide a copy of this Order,
by personal service or registered mail, to each of
their directors, officers, agents, representatives,
employees, attorneys, successors, and assigns, and
any and all persons in active concert or participation
with any of them. Defendants shall also post a copy
of this Order in the employee common areas at all of
their manufacturing facilities. Within thirty (30)
calendar days of the date of entry of this Order, defendants
shall provide to FDA an affidavit of compliance, based
upon personal knowledge of the affiant, stating the
fact and manner of compliance with the provisions of
this paragraph and identifying the names and positions
of all persons who have received a copy of this Order.
- Defendants shall notify FDA at least fifteen (15)
calendar days before change in ownership or character
of their business, such as reorganization, relocation,
dissolution, assignment, or sale resulting in the emergence
of a successor entity, the creation or dissolution
of subsidiaries, or any other change in the corporate
structure of Shelhigh, or in the sale or assignment
of any business assets, such as buildings, equipment,
or inventory, that may affect compliance obligations
arising out of this Order. Defendants shall provide
a copy of this Order to any potential successor or
assignee at least fifteen (15) calendar days prior
to any sale or assignment. Defendants shall furnish
FDA with an affidavit of compliance with this paragraph
no later than ten (10) calendar days before any change
in ownership or character of their business.
- Defendants and defendants' expert(s) shall address
all communications with FDA required under this Order
to the Director, Division of Enforcement B, 2098 Gaither
Road, Rockville, MD 20850 and the Director, New Jersey
District Office, U.S. Food and Drug Administration,
10 Waterview Boulevard, 3rd Floor, Parsippany, New
Jersey 07054.
- If any defendant fails to comply with any of the
provisions of this Order, upon motion of the United
States, that defendant shall pay to the United States
of America the sum of four thousand dollars ($4,000)
in liquidated damages for each day of the violation
and, in addition, four thousand dollars ($4,000) for
each violation. Defendants understand and agree that
the liquidated damages specified in this paragraph
are not punitive in nature and that they do not in any
way limit the ability of the United States to seek, and
the Court to impose, additional civil and criminal contempt
penalties based on conduct that may also form the basis
for the payment of liquidated damages.
- Should the United States bring and prevail in a contempt
action to enforce the terms of this Order, defendants
shall, in addition to other remedies, reimburse the United
States for its attorneys' fees, court costs, expert witness
fees, and investigational and analytical expenses incurred
in bringing such an action.
- All decisions specified in this Order shall be vested
in the discretion of FDA. FDA's
decisions shall be final and, to the extent that these
decisions are subject to review, shall be reviewed by
the Court under the arbitrary and capricious standard
set forth in 5 U.S.C. § 706(2)(A). Review
by a Court of any FDA decision rendered pursuant to this
Order shall be conducted without discovery and shall
be based exclusively upon the written record that was
before FDA at the time the decision was made.
- If defendants maintain a continuous state of compliance
with the CGMP/QS regulation requirements as set forth
at 21 C.F.R. Part 820, the MDR reporting requirements
set forth at 21 C.F.R. Part 803, and this Order, for
a period of five (5) years after the date of entry
of this Order and the FDA has not notified defendants
that there has been a significant violation of this
Order, the CGMPIQS regulation requirements as set forth
at 21 C.F.R. Part 820, and the MDR reporting requirements
set forth at 21 C.F.R. Part 803, the government will
not oppose defendants' motion to dissolve this Order.
- Defendants and defendants' counsel represent that
they have been advised by food and drug counsel regarding
the terms of this Order and that they understand and
agree with its provisions.
- All agreements between the parties are set forth
in this Order and there are no other understandings,
written or verbal, not contained herein. The parties
further agree that any change to this Order must be in
writing, signed by both parties, and agreed to by the
Court.
- This Court retains jurisdiction to issue such further
decrees and orders as may be necessary to enforce or
modify this Order and for granting such other relief
as may be necessary to appropriate for the proper disposition
of this proceeding.
SO ORDERED:
Dated this: [Handwritten
22nd]
day of [Handwritten June],
2007.
|
[Handwritten Signature]
UNITED STATES DISTRICT JUDGE |
We
hereby consent to the entry of the foregoing
Decree.
|
SHELHIGH, INC.
By: [Handwritten Signature]
Shlomo Gabbay, M.D.
Individually and as President of Shelhigh, Inc.
[Handwritten Signature]
Lea Gabbay, Individually
[Handwritten Signature]
Carmel E. Gabbay
Counsel for Shelhigh, Inc.,
Eric M. Blumberg
Shlomo Gabbay, M.D.,and
Lea Gabbay
650 Liberty Ave.,
Union, New Jersey
(908) 206-8706 |
CHRISTOPHER J. CHRISTE
United States Attorney
[Handwritten Signature]
Eugene Thirolf
Director,
Office of Consumer Litigation
U.S. Department of Justice
P.O. Box 386
Washington, D.C. 20044
(202) 307-3009
[Handwritten Signature]
Eric M. Blumberg
Special Assistant U.S. Attorney
5600 Fishers Lane, Room 6-13
Rockville, MD 20857
(301) 827-1138
OF COUNSEL:
DANIEL MERON
General Counsel
SHELDON BRADSHAW
Associate General Counsel
Food and Drug Division
JENNIFER E. CARUSO
MARCI B. NORTON
Associate Chief Counsels
Unite States Department of
Health and Human Services
Office of the General Counsel
Food and Drug Administration
5600 Fishers Lane,
Rockville, Maryland 20857 |
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