United States of America v. N.Y. Fish, Inc. et al

Filing 65

AMENDED JUDGMENT AND REVISED ORDER OF PERMANENT INJUNCTION in favor of the United States of America against New York City Fish, Inc., Leonid Staroseletsky, Maxim Kutsyk, Pavel Roytkov, issued for the reasons set forth in the Government's request [Doc No. 64]. Ordered by Judge Roslynn R. Mauskopf on 4/3/2014. (Schaeffer, Jarrod)

UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF NEW YORK
---------------------------------------------------------------)(
UNITED STATES OF AMERICA,
:
:
Plaintiff,
:
: Civil Action No. 1:13-cv-02909-RRM
v.
:
:
: REVISED ORDER OF
NEW YORK CITY FISH, INC., a corporation,
: PERMANENT INJUNCTION
MAXIM KUTSYK, an individual,
:
PAVEL ROYTKOV, an individual, and
:
LEONID STAROSELETSKY, an individual,
:
:
:
Defendants. :
---------------------------------------------------------------)(
INTRODUCTION
Plaintiff, the United States of America, having filed a Complaint for Injunction against
New York City Fish, Inc., a corporation; and Maxim Kutsyk, Pavel Roytkov, and Leonid
Staroseletsky, individuals (collectively, “Appearing Defendants”), a Motion for Preliminary
Injunction with a supporting memorandum of law, the declarations of (1) Ronald M. Pace,
Director of the New York District Office of the U.S. Food and Drug Administration (“FDA”);
(2) Mary E. Losikoff, Consumer Safety Officer, Office of Food Safety, FDA’s Center for Food
Safety and Applied Nutrition (“CFSAN”); and (3) Christine E. Keys, Microbiologist, CFSAN’s
Office of Regulatory Science; a reply memorandum in further support of its motion for
preliminary injunction; a declaration in advance of trial from Peter M. Trunk, Consumer Safety
Officer, Director of FDA’s New York District Office; a second declaration in advance of trial
from Mary Losikoff; and this Court having considered such documents, all documents filed by
Appearing Defendants, and the arguments and live testimony at the hearing on July 9 and 10,
2013 consolidating the United States’ Motion for Preliminary Injunction and request for a

permanent injunction in its Complaint for Injunction; and it appearing that Appearing Defendants
are violating the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq. (“the Act”), and
unless restrained by order of this Court, may continue to violate the Act,
IT IS HEREBY ORDERED that:
I.

This Court has jurisdiction over the subject matter and over all parties to this

action pursuant to 21 U.S.C. § 302.
II.

The Complaint for Injunction states a claim for relief against Appearing

Defendants under the Act.
III.

The United States has succeeded on the merits of its claims that Appearing

Defendants violate the Act, 21 U.S.C. § 33l(a), by introducing, or delivering for introduction,
into interstate commerce articles of food that are adulterated within the meaning of 21 U.S.C. §
342(a)(4), and the public interest weighs heavily in favor of granting the permanent injunctive
relief sought by the United States.
IV.

The United States has succeeded on the merits of its claim that Appearing

Defendants violate the Act, 21 U .S.C. § 331 (k), by causing articles of food to be adulterated
within the meaning of 21 U.S.C. § 342(a)(4) while such articles are held for sale after shipment
of one or more ingredients in interstate commerce, and the public interest weighs heavily in favor
of granting the permanent injunctive relief sought by the United States.
V.

Upon entry of this Order, Appearing Defendants and each and all of their

directors, officers, agents, employees, representatives, successors, assigns, heirs, attorneys, and
any persons in active concert or participation with any of them (including individuals, directors,
corporations, subsidiaries, affiliates, and partnerships) are hereby restrained and enjoined, under
the provisions of 21 U.S.C. § 332(a) and the inherent equitable authority of this Court, from

directly or indirectly receiving, preparing, processing, packing, holding, and distributing articles
of food, at or from their facility located at 738 Chester St., Brooklyn, New York 11236-1925 (the
“Chester Street Facility”), and/or any other location(s) at or from which Appearing Defendants,
now or in the future, receive, process, prepare, pack, hold, or distribute articles of food, unless
and until:
A.

Appearing Defendants retain, at their expense, an independent laboratory

(the “laboratory”) having no personal or financial ties (other than the retention agreement) to
Appearing Defendants or their families, which is qualified to collect product and environmental
samples from within the Chester Street Facility and analyze those samples for the presence of
Listeria monocytogenes (“L. mono”) using a method that is acceptable to the FDA. Appearing
Defendants shall notify FDA in writing immediately upon retaining such laboratory and shall
provide FDA a copy of the service contract. Such service contract shall contain provisions,
acceptable to FDA, for regular environmental and finished product sample collection and
analyses, including how and where to sample, the number and frequency of samples to be
collected, and the methods of analyses, in accordance with the Listeria Monitoring Program
discussed in paragraph V(C) below;
B.

Appearing Defendants retain, at their expense, an independent expert(s)

(the “Sanitation Expert”) having no personal or financial ties (other than the retention agreement)
to Appearing Defendants or their families, and who, by reason of background, education,
training, and experience, is qualified to develop a Listeria Monitoring Program, to inspect the
Chester Street Facility, and to determine whether the methods, facilities, and controls are
operated and administered in conformity with the Act, its implementing regulations, and this
Order. Appearing Defendants shall notify FDA in writing of the name(s) and qualifications of

the Sanitation Expert as soon as they retain such expert;
C.

Appearing Defendants’ Sanitation Expert, in consultation with the

laboratory, after review of all FDA observations from 2006 to present, develops a written
Listeria Monitoring Program, which shall include, at a minimum, the following:
(1)

An effective written sanitation control program that establishes

adequate methods, facilities, and controls for receiving, preparing, processing, packing, holding
and distributing articles of food to minimize the risk of introducing L. mono, other pathogenic
organisms, and filth into Appearing Defendants’ food, and to ensure that foods are not
adulterated within the meaning of 21 U.S.C. § 342(a). Such methods, facilities, and controls
shall include, but shall not be limited to, thoroughly cleaning, sanitizing, renovating, and
rendering the Chester Street Facility and all equipment therein suitable for use in receiving,
preparing, processing, packing, holding, and distributing articles of food to prevent such articles
from becoming adulterated, and instituting standard sanitation operating procedures (“SSOPs”)
to ensure that the Chester Street Facility and equipment therein are continuously maintained in a
sanitary condition. An effective written sanitation control program during the period of time
when Appearing Defendants are enjoined under Paragraph V shall include completely
disassembling all of the equipment and thoroughly cleaning and sanitizing the disassembled
equipment by soaking the equipment parts in quaternary ammonia overnight, applying steam to
larger pieces of equipment after they have been thoroughly cleaned and sanitized, and fogging
rooms with a sanitizer solution;
(2)

A written employee training program (in English, Spanish, and

Russian, and any other language that is necessary to convey the substance of the training
program to the employees) that includes, at a minimum, instructions on sanitary food handling

techniques and documentation that each employee has received such training. The employee
training program shall include, at a minimum, basic training for all employees on the importance
of Listeria controls and their role in Listeria control strategies, training for all employees who
handle or work in exposed finished product areas to ensure that they understand how to prevent
cross-contamination of product, and training for all employees who conduct cleaning and
sanitation tasks or activities to ensure that they understand the sanitation procedures necessary to
reduce or eliminate Listeria in the plant. Appearing Defendants’ Sanitation Expert shall ensure
that each employee fully understands the substance of the employee training program;
(3)

An effective program for environmental monitoring and testing of

the Chester Street Facility to ensure that such organisms as Listeria species (“L. spp.”) are
controlled, and that the pathogen L. mono is not present within the facility. Environmental
monitoring shall include, but not be limited to, collecting swab samples from food-contact
surfaces, equipment, and other environmental sites throughout the Chester Street Facility (where
the raw ingredients, in-process, and finished articles of foods are received, prepared, processed,
packed, held, and/or distributed, and common areas that could be reservoirs for crosscontamination), and analysis of collected samples, in a manner acceptable to FDA. Appearing
Defendants shall ensure that the results of all analyses conducted pursuant to this paragraph are
sent to FDA within two (2) calendar days after receipt by Appearing Defendants; and
(4)

A written plan for remedial action, which is acceptable to FDA,

should L. spp. or L. mono be detected;
D.

Appearing Defendants assign continuing responsibility for the operation of

the Listeria Monitoring Program discussed in Paragraph V(C) above to a person (or persons),
who, by reason of background, experience, or education, is competent to maintain the Chester

Street Facility in a sanitary condition, coordinate with the laboratory, and implement any
necessary remedial action(s), and provide such person(s) with the authority to achieve the
necessary corrections;
E.

Appearing Defendants make versions of the Listeria Monitoring Program

(in English, Spanish, Russian, and any other language necessary to convey the substance of the
Listeria Monitoring Program to their employees) available and accessible to all their employees;
F.

FDA approves, in writing, the Listeria Monitoring Program discussed in

paragraph V(C) above;
G.

The Sanitation Expert conducts a comprehensive inspection of the Chester

Street Facility and the methods and controls used to receive, prepare, process, pack, hold, and
distribute foods to determine whether the Appearing Defendants have effectively implemented
all corrections and are operating in compliance with this Order, the Act, and its implementing
regulations. The Sanitation Expert shall submit all findings to Appearing Defendants and FDA
concurrently, within ten (10) business days after completion of the inspection;
H.

Appearing Defendants retain a person or persons (the “HACCP Expert” or

“HACCP Experts”) who is/are without any personal or financial ties (other than the consulting
agreement) to Appearing Defendants or their families, and who by reason of background,
experience, and education, is qualified to:
(1)

Conduct hazard analyses to develop adequate HACCP plans for

the processing of each type of fish and fishery product Appearing Defendants intend to process,
as required by 21 C.F.R. § 123.6(a)-(c);
(2)

Verify the adequacy of Appearing Defendants’ HACCP plans, as

required by 21 C.F.R. § 123.8;

(3)

Develop adequate SSOPs specific to Appearing Defendants, as

required by 21 C.F.R. § 123.11;
(4)

Evaluate Appearing Defendants’ monitoring of key sanitation

conditions and practices, as set forth in 21 C.F.R. § 123.11(b);
(5)

Develop and conduct employee training programs (in English,

Spanish, Russian, and any other language that is necessary to convey the substance of the
training to the employees) on the seafood HACCP regulations;
(6)

Inspect the Chester Street Facility and establish procedures to

ensure that the methods, facilities, and controls for processing fish and fishery products are
continuously operated and administered in conformity with the Act and all applicable
regulations.
Appearing Defendants shall notify FDA in writing of the identity and qualifications of
the HACCP Expert and provide FDA with information in writing regarding the HACCP Expert’s
qualifications, background, experience, and/or education under Paragraphs V(H)(1)-(6) as soon
as such Expert is retained. Appearing Defendants’ HACCP Expert may be the same individual
or individuals as Appearing Defendants’ Sanitation Expert;
I.

The HACCP Expert retained by Appearing Defendants develops and

submits to FDA:
(1)

Adequate written HACCP plans for each type of fish and fishery

product, received, prepared, processed, packed, held, and/or distributed by Appearing
Defendants for which food safety hazards are identified, including appropriate critical control
points, critical limits, monitoring procedures, recordkeeping, etc., as required by 21 C.F.R.
§ 123.6;

(2)

Adequate written SSOPs, as required by 21 C.F.R. § 123.11;

(3)

Adequate written corrective action plans, as part of the seafood

HACCP plans, to be taken whenever there is a deviation from the critical limit, as described in
21 C.F.R. § 123.7(b);
(4)

Employee training programs (in English, Spanish, Russian, and

any other language necessary to convey the substance of the training programs to the employees)
on the seafood HACCP regulations, SSOPs, and control strategies specific to Appearing
Defendants’ fish and fishery products;
J.

FDA has approved, in writing, the seafood HACCP plan(s), SSOPs, and

training program developed by the HACCP Expert, as specified in paragraphs V(I)(1)-(4);
K.

Appearing Defendants successfully complete the employee training

program developed by the HACCP Expert and approved by FDA according to paragraph VIII(J).
L.

Appearing Defendants report to FDA, in writing, the actions they have

taken to bring their seafood operations into compliance with this Order, the Act, and all
applicable regulations, including the specific measures Appearing Defendants have taken to
address each of the seafood HACCP deficiencies documented by FDA at the Chester Street
Facility since August 2012;
M.

The HACCP Expert conducts a comprehensive inspection of the facility

and the methods and controls used to receive, prepare, process, pack, hold, and distribute fish
and fishery products to determine whether Appearing Defendants’ processing facility is sanitary
and Appearing Defendants are fully prepared to operate in compliance with this Order, the Act,
and all applicable regulations. The HACCP Expert shall verify that Appearing Defendants have
corrected all of the seafood HACCP deficiencies documented by FDA. The HACCP expert shall

submit all findings, in writing, to Appearing Defendants and FDA concurrently, within ten (10)
business days of completion of the inspection;
N.

FDA, as it deems necessary to evaluate Appearing Defendants’

compliance with the terms of this Order, the Act, and all applicable regulations, conducts
inspections of the Chester Street Facility, including the building, sanitation-related systems,
equipment, utensils, articles of food, and relevant records, contained therein;
O.

Appearing Defendants report to FDA in writing the actions they have

taken to bring their operations into compliance with the Act and all applicable regulations,
including:
(1)

Documentation that Appearing Defendants have cleaned and

sanitized the Chester Street Facility and equipment therein and made improvements, thereby
rendering the facility and equipment suitable for receiving, processing, preparing, packing,
holding, and distributing articles of food, and documentation that Appearing Defendants have
conducted environmental testing in a manner acceptable to the FDA and received laboratory
results showing that L. mono is no longer present in the facility;
(2)

Specific measures that they have taken to address each of the

violations documented by FDA since August 2012; and
(3)

A copy of the Listeria Monitoring Program discussed in Paragraph

V(C) above;
P.

Within thirty (30) calendar days after entry of this Order, Appearing

Defendants destroy, under FDA’s supervision, and according to a destruction plan submitted in
writing by Appearing Defendants and approved in writing by FDA prior to implementation, all
in-process and finished articles of food currently in their custody, control, or possession;

Q.

FDA, as it deems necessary to evaluate Appearing Defendants’

compliance with the terms of this Order, the Act, and all applicable regulations, conducts
inspections of the Chester Street Facility, including the buildings, sanitation-related systems,
equipment, utensils, all articles of food, and relevant records contained therein;
R.

FDA notifies Appearing Defendants in writing that Appearing Defendants

appear to be in compliance with the requirements set forth in paragraph V(A) through (P) of this
Order, the Act, and its implementing regulations; and
S.

Appearing Defendants have paid all costs of inspection, analyses, review,

investigations, examination, and supervision for FDA’s oversight with respect to paragraph V(A)
through (R), at the rates set forth in paragraph XII below.
VI.

Immediately upon resuming operations after completing the requirements of

paragraph V, Appearing Defendants shall, in consultation with the laboratory and the Sanitation
Expert and HACCP Expert, continuously implement the following steps to prevent further
contamination from L. mono, other pathogenic organisms, or filth in their food products and
facility:
A.

Effectively implement on an ongoing basis, the Listeria Monitoring

Program developed pursuant to paragraph V(C).
B.

Conduct environmental monitoring and testing to ensure that the SSOPs

continue to eliminate the L. mono hazard and that the SSOPs are consistently being followed.
Environmental monitoring shall include collecting swab samples from food-contact and nonfood-contact surfaces, equipment, and other environmental sites throughout the Chester Street
Facility (where articles of food are received, prepared, processed, packed, and held, up to and
including final packaging, as well as common areas), and analyzing such samples for the

presence of L. spp. Environmental testing for L.spp. shall be performed by the laboratory in
accordance with timetables and methods that Appearing Defendants submit to FDA in writing
for approval by FDA in writing before testing begins. Appearing Defendants shall ensure that
the results of all testing conducted pursuant to this paragraph are forwarded to FDA within two
(2) calendar days after receipt by Appearing Defendants. Appearing Defendants’ environmental
testing must include, at a minimum, all of the following:
(1)

If a food- or non-food-contact surface is found to be positive for L.

spp. during routine sampling performed in accordance to the timetables and methods approved
by FDA in Paragraph VI(B), intensified sampling must be done as soon as possible, in
conjunction with intensified sanitation measures. Intensified sampling requires that three (3)
samples per day must be collected and analyzed until at least nine (9) consecutive samples (three
(3) days of intensified sampling) have been taken and are negative for L. spp. from the site where
the L. spp. was identified. After nine (9) consecutive samples are tested and found to be
negative, that site may return to routine sampling; and
(2)

All food products that have been present in a site that tests positive

for the general strain L. spp. must be placed on hold pending laboratory test results. The
products can be released only if laboratory test results are negative for L. mono; if the laboratory
results are positive for L. mono, all food products held, packed, and processed since the date of
the last negative environmental swab for that site must be destroyed at Appearing Defendants’
expense, under FDA’s supervision, and according to a written destruction plan submitted by
Appearing Defendants and approved, in writing, by FDA prior to implementation; and
C.

Conduct finished product testing in the following manner:
(1)

Appearing Defendants shall test for L. mono in each batch food

product for at least five (5) consecutive production days using a testing method approved in
writing in advance by FDA;
(2)

After the completion of testing under paragraph VI(C)(1),

Appearing Defendants shall test at least one lot of each food product per day for the next twenty
(20) production days;
(3)

After the completion of testing under paragraph VI(C)(2),

Appearing Defendants shall test at least one lot of each food product per every five (5)
production days for the next three (3) months; and
(4)

After the completion of testing under paragraph VI(C)(3),

Appearing Defendants shall test at least one lot of each food product per month thereafter.
If any laboratory test completed pursuant to paragraphs VI(C)(1)-(4) shows the presence
of L. mono in any article of food, then Appearing Defendants must immediately cease production
and notify FDA that production has ceased. Appearing Defendants shall also destroy, at
Appearing Defendants’ expense, under FDA’s supervision, and according to a destruction plan
submitted in writing by Appearing Defendants and approved prior to implementation, in writing,
by FDA, all food products held, packed, and processed since the date of the last negative
environmental swab for that site. Appearing Defendants may resume production only when they
have determined and corrected the cause of the contamination and only after FDA notifies
Appearing Defendants in writing that Appearing Defendants appear to be in compliance with the
requirements of this Order, the Act, and its implementing regulations. After correcting the cause
of the contamination, Appearing Defendants shall reinstate the complete sequence of testing
under this paragraph anew. Appearing Defendants shall ensure that the results of all testing
conducted under this paragraph are forwarded to FDA within two (2) calendar days after receipt

by Defendant.
VII.

If, after notifying FDA of the name of the laboratory retained to conduct sample

collection and analyses pursuant to paragraph V(A), Appearing Defendants terminate or in any
way alter their service contract with the laboratory, Appearing Defendants shall notify FDA
within five (5) business days. If Appearing Defendants terminate their service contract,
Appearing Defendants shall provide a copy of the service contract with the new laboratory to
FDA within five (5) business days of execution.
VIII.

Immediately upon resuming operations after completing the requirements set

forth in paragraph V, Appearing Defendants shall, in consultation with the Sanitation Expert and
HACCP Expert, continuously implement the SSOPs, and seafood HACCP and training programs
developed by the HACCP Expert and approved by FDA according to paragraph V(J). Within
thirty (30) days after Appearing Defendants’ resumption of their seafood operations, the HACCP
expert shall conduct a comprehensive inspection of the facility and the methods and controls
used to receive, prepare, process, pack, hold, and distribute foods to determine whether the
Appearing Defendants are operating in compliance with this Order, the Act, and all applicable
regulations. The HACCP Expert shall conduct one inspection after ninety (90) days, and then
one inspection every one hundred and eighty days (180) for the next three (3) years, and then one
inspection annually for an additional two (2) years.
IX.

Appearing Defendants and each and all of their officers, agents, employees,

representatives, successors, assigns, heirs, attorneys, and any and all persons in active concert or
participation with any of them (including individuals, directors, corporations, subsidiaries,
affiliates, and partnerships) who receive actual notice of this Order, are restrained and enjoined
under the provisions of 21 U.S.C. § 332(a) from directly or indirectly doing or causing any act

that:
A.

Violates the Act, 21 U.S.C. § 331(a), by introducing and/or delivering for

introduction into interstate commerce, any article of food, within the meaning of 21 U.S.C.
§ 321(f), that is adulterated, within the meaning of 21 U.S.C. § 342(a)(4);
B.

Violates 21 U.S.C. § 331(k), by causing any article of food within the

meaning of 21 U.S.C. § 321(f) to become adulterated within the meaning of 21 U.S.C.
§ 342(a)(4) while such article is held for sale after shipment of one or more of its components in
interstate commerce; and/or
C.

Results in the failure to implement and continuously maintain the

requirements of this Order.
X.

FDA shall be permitted, without prior notice and as and when FDA deems

necessary, to make inspections of the Chester Street Facility, and any other locations at which
Appearing Defendants receive, prepare, process, pack, hold, or distribute articles of food and,
without prior notice, to take any other measures necessary to monitor and ensure continuing
compliance with the terms of this Order, the Act, and its implementing regulations. During the
inspections, FDA shall be permitted to have immediate access to buildings, equipment, raw
ingredients, in-process and finished articles of food, containers, and packaging material therein;
to take photographs and make video recordings; to take samples of Appearing Defendants’ raw
ingredients, in-process, and finished articles of food, containers, and packaging material; and to
examine and copy all records related to receiving, preparing, processing, packing, holding, and
distributing any and all articles of food. The inspections shall be permitted 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.
XI.

Appearing Defendants shall notify FDA in writing at least fifteen (15) calendar

days before any change in ownership, name, or character of their business, including
reorganization, relocation, dissolution, assignment, or lease or sale of the business or any assets
of the business, such as buildings, equipment, or inventory, that may affect compliance with the
obligations arising from this Order. Appearing Defendants shall provide any prospective
successor or assign with a copy of this Order at least ten (10) calendar days before the
assignment or change in business, and shall provide FDA with an affidavit of compliance with
this paragraph within ten (10) calendar days of providing a copy of this Order to a prospective
successor or assign.
XII.

Appearing Defendants shall pay all costs of FDA’s supervision, inspections,

investigations, analyses, examinations, and reviews that FDA deems necessary to evaluate
Appearing Defendants’ compliance with this Order, at the standard rates prevailing at the time
costs are incurred, and Appearing Defendants shall make payment in full to FDA within (30)
calendar days of receiving written notification from FDA of the costs. As of the date that this
Order is signed by the parties, these rates are: $87.57 per hour and fraction thereof per
representative inspection work; $104.96 per hour or fraction thereof per representative analytical
or review work; $0.565 per mile for travel by automobile; government rate or the 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 representative and per day for subsistence
expenses, where necessary. In the event that the standard rates applicable to FDA supervision of
court-ordered compliance are modified, these rates shall be increased or decreased without
further order of the Court.

XIII.

If, at any time after entry of this Order, FDA determines, based on the results of

an inspection, sample, analyses, or other information, that Appearing Defendants have failed to
comply with any provision of this Order, have violated the Act or its implementing regulations,
or that additional corrective actions are necessary to achieve compliance with this Order, the Act
or its implementing regulations, FDA may, as and when it deems necessary, notify Appearing
Defendants in writing and order Appearing Defendants to take appropriate action, including, but
not limited to, ordering Appearing Defendants to immediately take one or more of the following
actions:
A.

Cease receiving, preparing, processing, packing, holding, and distributing

any articles of food;
B.

Recall all articles of food that have been distributed and/or are under the

custody and control of Appearing Defendants’ agents, distributors, customers, or consumers;
C.

Submit samples of articles of food to a qualified laboratory to determine

whether they are contaminated with chemicals, toxins, microorganisms, or filth;
D.

Assess liquidated damages, as provided by paragraph XVI of this Order;

E.

Take any other corrective actions as FDA deems necessary to bring

and/or

Appearing Defendants into compliance with this Order, the Act, and its implementing
regulations.
The provisions of this paragraph shall be separate and apart from, and in addition to, all
other remedies available to FDA. Appearing Defendants shall pay all costs of recalls and other
corrective actions, including the costs of FDA’s supervision, inspections, investigations,
analyses, examinations, review, travel, and subsistence expenses to implement and monitor

recalls and other actions, at the rates specified in paragraph XII of this Order.
XIV. Upon receipt of any order issued by FDA pursuant to paragraph XIII, Appearing
Defendants shall immediately and fully comply with the terms of the order. Any cessation of
operations or other action as described in paragraph XIII shall be implemented immediately upon
notice from FDA and shall continue until Appearing Defendants receive written notification
from FDA that Appearing Defendants appear to be in compliance with the Order, the Act, and its
implementing regulations. After a cessation of operations, and while determining whether
Appearing Defendants are in compliance with this Order, the Act, and its implementing
regulations, FDA may require Appearing Defendants to re-institute or re-implement any of the
requirements of this Order.
XV.

Appearing Defendants shall maintain copies of their HACCP plans, along with

copies of all records required by the plans and by 21 C.F.R. Part 123, at their facility in a
location where they are readily available for reference and inspection by FDA officials. All
records required to be kept by the HACCP plans and by the regulations shall be retained for at
least three (3) years after the date the records are prepared.
XVI. If any Defendant violates this Order and is found in contempt thereof, Appearing
Defendants shall, in addition to other remedies, reimburse the United States for its attorneys’
fees, travel expenses incurred by attorneys and witnesses, expert witness fees, administrative and
court costs, investigation and analytical expenses incurred in bringing the contempt action, and
any other costs or fees related to the contempt proceedings.
XVIII. All decisions specified in this Order shall be vested in the discretion of FDA.
FDA’s decisions shall be final and shall be reviewed by the Court under the arbitrary and
capricious standard set forth in 5 U.S.C. § 706(2)(A). Review by the Court of any FDA decision

rendered pursuant to this Order shall be based exclusively on the written record before the FDA
at the time the decision was made. No discovery shall be taken by either party.
XIX. Within ten (10) calendar days after entry of this Order, Appearing Defendants
shall provide a copy of this Order to each and all of their officers, agents, employees,
representatives, successors, assigns, heirs, attorneys, and any and all persons in active concert or
participation with any of them (including individuals, directors, corporations, subsidiaries,
affiliates, and partnerships) (in English, Spanish, Russian, and any other language necessary to
convey the substance of the Order to those individuals). Appearing Defendants shall provide to
FDA within thirty (30) calendar days of the date of the entry of this Order, an affidavit of
compliance with this paragraph stating the fact and manner of compliance and identifying the
names and positions of all persons so notified.
XX.

Appearing Defendants shall prominently post a copy of this Order (in English,

Spanish, Russian, and any other language necessary to convey the substance of the Order to the
employees) in an employee common area at the Chester Street Facility within ten (10) calendar
days of the entry of this Order and shall ensure that the Order remains posted for a period of at
least six (6) months.
XXI. Appearing Defendants shall, within ten (10) calendar days of the entry of this
Order, hold a general meeting or a series of smaller meetings for employees of the facility, at
which they shall describe the terms and obligations of this Order (in English, Spanish, Russian,
and any other language necessary to convey the substance of the Order to the employees).
XXII. In the event that any Appearing Defendant becomes associated with any
additional officers, agents, employees, representatives, successors, assigns, heirs, attorneys, or
any additional persons in active concert or participation with any of them (including individuals,

directors, corporations, subsidiaries, affiliates, and partnerships) at any time after entry of this
Order, Appearing Defendants shall immediately provide a copy of this Order, by personal
service or certified mail (restricted delivery, return receipt requested), to such persons. Within
ten (10) calendar days of each instance that an Appearing Defendant becomes associated with
any such individual persons, Appearing Defendants shall provide to FDA an affidavit stating the
fact and manner of Appearing Defendants’ compliance with this paragraph, identifying the
names, addresses, and positions of all persons who received a copy of this Order pursuant to this
paragraph, and attaching a copy of the executed certified mail return receipts. Within ten (10)
calendar days of receiving a request from FDA for any information or documentation that FDA
deems necessary to evaluate Appearing Defendants’ compliance with this paragraph, Appearing
Defendants shall provide such information or documentation to FDA.
XXIV. Appearing Defendants shall address all communications required under this Order
to the Director, New York District Office, United States Food and Drug Administration, 158-15
Liberty Avenue, Jamaica, New York 11433, and shall reference this civil action by case name
and civil action number in such communications.
XXV. Appearing Defendants Roytkov and Staroseletsky shall notify the Court and FDA
if, at any time after entry of this Order, either Defendant ceases to be employed by or affiliated in
any way with Defendant NYC Fish and Defendant Kutsyk. Appearing Defendants Roytkov and
Staroseletsky may, after providing thirty (30) calendar days’ written notice, petition the Court to
be released from Paragraphs V-VIII this Order. Unless, within such 30-day period, FDA
determines that either Appearing Defendants Roytkov and Staroseletsky has not ceased to be
employed by or affiliated with Defendant NYC Fish or Defendant Kutsyk, FDA will not oppose
release of such individual Defendant from the above-referenced terms of the Order pursuant to

such petition.
XXVI. This Court retains jurisdiction of this action and the parties hereto for the purpose
of enforcing and modifying this Order and for the purpose of granting such additional relief as
may be necessary and appropriate.
SO ORDERED:
Dated this 3rd day of April, 2014.

Roslynn R. Mauskopf
_____________________________
HON. ROSLYNN R. MAUSKOPF
UNITED STATES DISTRICT JUDGE