`
`Case 1:22-cv-01380-NLH-SAK Document 8-1 Filed 03/24/22 Page 1 of 16 PageID: 40Case 1:22-cv-01380-NLH-SAK Document 9 Filed 03/28/22 Page 1 of 16 PageID: 56
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`UNITED STATES OF AMERICA,
`
`Plaintiff,
`
`v.
`
`BRAVO PACKING, INC., a corporation, and
`JOSEPH MEROLA and AMANDA LLOYD,
`individuals,
`
`Defendants.
`
`22-cv-1380-NLH-SAK
`Civil Action No. __________
`Hon. Noel L. Hillman
`Hon. Sharon A. King
`
`CONSENT DECREE OF PERMANENT INJUNCTION
`
`Plaintiff, the United States of America, by its undersigned attorneys, having filed a
`
`Complaint for Injunction against Bravo Packing, Inc. (“Bravo”) and Joseph Merola and Amanda
`
`Lloyd (collectively, “Defendants”), and Defendants having appeared and consented to the entry
`
`of this Consent Decree of Permanent Injunction (“Decree”) without contest, without admitting or
`
`denying the allegations in the Complaint, and before any testimony has been taken, and the
`
`United States of America having consented to this Decree;
`
`IT IS HEREBY ORDERED, ADJUDGED, AND DECREED that:
`
`action.
`
`1.
`
`2.
`
`This Court has jurisdiction over the subject matter and over all parties to this
`
`The Complaint for Injunction states a cause of action against Defendants under
`
`the Federal Food, Drug, and Cosmetic Act (“the Act”), 21 U.S.C. §§ 301 et seq.
`
`3.
`
`The Complaint alleges Defendants violate the Act, 21 U.S.C. § 331(a), by
`
`introducing or delivering for introduction into interstate commerce, or the causing thereof,
`
`

`

`
`
`Case 1:22-cv-01380-NLH-SAK Document 8-1 Filed 03/24/22 Page 2 of 16 PageID: 41Case 1:22-cv-01380-NLH-SAK Document 9 Filed 03/28/22 Page 2 of 16 PageID: 57
`
`articles of animal food within the meaning of 21 U.S.C. § 321(f), namely raw pet food products,
`
`that are adulterated.
`
`
`
`4.
`
`The Complaint alleges Defendants violate the Act, 21 U.S.C. § 331(k), by causing
`
`the adulteration of articles of pet food while such articles are held for sale after shipment of one
`
`or more components in interstate commerce.
`
`
`
`5.
`
`The Complaint alleges articles of pet food are adulterated within the meaning of
`
`21 U.S.C. § 342(a)(1) in that they bear or contain a poisonous or deleterious substance, namely
`
`Salmonella, which may render them injurious to health, and within the meaning of 21 U.S.C. §
`
`342(a)(4) in that they have been prepared, packed, or held under insanitary conditions whereby
`
`they may have become contaminated with filth or rendered injurious to health.
`
`
`
`6.
`
`Upon entry of this Decree, the Defendants and each and all of their agents,
`
`representatives, employees, attorneys, successors, and assigns, and any and all persons in active
`
`concert or participation with any of them who receive actual notice of this Decree by personal
`
`service or otherwise, are permanently restrained and enjoined under 21 U.S.C. § 332(a) and the
`
`inherent equitable authority of this Court, from directly or indirectly receiving, processing,
`
`manufacturing, preparing, packing, holding, and/or distributing pet food, at or from their facility
`
`at 59 N. Golfwood Ave., Carneys Point, New Jersey and any other locations at which Defendants
`
`now or in the future receive, process, manufacture, prepare, pack, hold, or distribute articles of
`
`pet food, unless and until:
`
`
`
`
`
`A.
`
`Defendants retain, at their expense, an independent laboratory (the
`
`“laboratory”) having no personal or financial ties (other than the retention agreement) to the
`
`Defendants or their families, which is qualified to collect finished raw pet food product and
`
`environmental samples from within the Defendants’ facility and analyze those samples for the
`
`
`
`2
`
`

`

`
`
`Case 1:22-cv-01380-NLH-SAK Document 8-1 Filed 03/24/22 Page 3 of 16 PageID: 42Case 1:22-cv-01380-NLH-SAK Document 9 Filed 03/28/22 Page 3 of 16 PageID: 58
`
`presence of Salmonella and Listeria monocytogenes (“L. mono”), and other pathogenic
`
`microorganisms, in a method that is acceptable to the FDA. The 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 certain provisions, acceptable to FDA, for regular
`
`environmental and finished raw pet food product sample collection and analysis, including how
`
`and where to sample, the number and frequency of samples to be collected, and the methods of
`
`analysis, in accordance with the Environmental Monitoring Program discussed in paragraph C
`
`below;
`
`
`
`
`
`B.
`
`Defendants retain, at their expense, an independent expert(s) (“sanitation
`
`expert”) having no personal or financial ties (other than the retention agreement) to the
`
`Defendants or their families, and who, by reason of background, education, training, and
`
`experience, is qualified to inspect the Defendants’ facility and to determine whether the methods,
`
`facilities, and controls are operated and administered in conformity with the Act and all
`
`applicable regulations. The Defendants shall notify FDA in writing of the name(s) and
`
`qualifications of the sanitation expert(s) as soon as they retain such expert(s);
`
`
`
`
`
`C.
`
`Defendants’ sanitation expert(s), in consultation with the laboratory, after
`
`review of all FDA observations cited on the List of Inspectional Observation (“Forms FDA
`
`483”) issued to the Defendants on May 28, 2021, April 7, 2021, and August 6, 2019, develop a
`
`written Environmental Monitoring Program, acceptable to FDA, which shall include, at a
`
`minimum, the following:
`
`
`
`
`
`
`
`i.
`
`An effective written sanitation control program that establishes
`
`adequate methods, facilities, and controls for receiving, processing, manufacturing, preparing,
`
`packing, holding, and distributing pet foods to minimize the risk of introduction of Salmonella
`
`
`
`3
`
`

`

`
`
`Case 1:22-cv-01380-NLH-SAK Document 8-1 Filed 03/24/22 Page 4 of 16 PageID: 43Case 1:22-cv-01380-NLH-SAK Document 9 Filed 03/28/22 Page 4 of 16 PageID: 59
`
`into the Defendants’ pet food and to ensure that the pet food is 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 Defendants’ facility
`
`and all equipment therein suitable for use in receiving, processing, manufacturing, preparing,
`
`packing, holding, and distributing articles of pet food to prevent the articles of pet food from
`
`becoming adulterated, and instituting procedures to ensure that the facility and equipment therein
`
`are continuously maintained in a sanitary condition;
`
`
`
`
`
`
`
`ii.
`
`A written employee training program, in English and Spanish, that
`
`includes, at a minimum, instruction on the principles of pet food hygiene and pet food safety,
`
`including the importance of employee health and personal hygiene, sanitary pet food handling
`
`techniques, and documentation that each employee has received such training;
`
`
`
`
`
`
`
`iii.
`
`An effective program of environmental monitoring and testing of
`
`the facility, conducted by the laboratory, to ensure that pathogenic microorganisms are not
`
`present within the facility, excluding the slaughter room. Environmental monitoring shall
`
`include, but not be limited to, collecting swab samples from pet food-contact surfaces,
`
`equipment, and other environmental sites throughout the facility (where the raw ingredients, in-
`
`process, and finished pet food products are received, processed, manufactured, prepared, packed,
`
`held, and/or distributed, and common areas that could be reservoirs for cross-contamination), and
`
`analysis of collected samples, in a manner acceptable to FDA. Defendants shall ensure that the
`
`results of all analyses conducted pursuant to this paragraph 6.C.iii are sent to FDA within two (2)
`
`business days of receipt by the Defendants;
`
`
`
`
`
`
`
`iv.
`
`A plan for remedial action should Salmonella, L. mono, or any
`
`other pathogenic microorganism be detected; and
`
`
`
`4
`
`

`

`
`
`Case 1:22-cv-01380-NLH-SAK Document 8-1 Filed 03/24/22 Page 5 of 16 PageID: 44Case 1:22-cv-01380-NLH-SAK Document 9 Filed 03/28/22 Page 5 of 16 PageID: 60
`
`
`
`
`
`
`
`v.
`
`Assigning continuing responsibility for the operation of the
`
`Environmental Monitoring Program to a person or persons who, by reason of background,
`
`experience, or education, is qualified to maintain the facility in a sanitary condition, coordinate
`
`with the laboratory, and implement any necessary remedial action(s), and providing such person
`
`with the authority and resources to achieve the necessary corrections.
`
`
`
`
`
`D.
`
`The sanitation expert(s) conducts a comprehensive inspection of the
`
`Defendants’ facility and the methods and controls used to receive, process, manufacture, prepare,
`
`pack, hold, and distribute pet foods to determine whether the Defendants have adequately
`
`established and implemented all necessary changes and are operating in compliance with this
`
`Decree, the Act, and the Current Good Manufacturing Practice (“CGMP”) requirements set forth
`
`in 21 C.F.R. Part 507. Defendants shall ensure that the expert(s) shall submit their findings from
`
`this inspection to the Defendants and FDA concurrently, within ten (10) business days of
`
`completion of the inspection;
`
`
`
`
`
`E.
`
`The sanitation expert certifies in writing to FDA that Defendants: (a) have
`
`adequately established and implemented the FDA-approved Environmental Monitoring Program
`
`pursuant to paragraph 6.C.iii; (b) have adequately addressed FDA investigators’ inspectional
`
`observations listed on each Form FDA-483 issued to the Defendants since 2019; and (c) comply
`
`with the CGMP requirements in 21 C.F.R. Part 507 including:
`
`
`
`
`
`
`
`i.
`
`Documentation that they have cleaned and sanitized their facility
`
`and have received laboratory results showing that Salmonella, L .mono, and other pathogenic
`
`microorganisms are no longer present in the facility;
`
`
`
`
`
`
`
`ii.
`
`Specific measures that they have taken to address each of the
`
`violations documented by FDA; and
`
`
`
`5
`
`

`

`
`
`Case 1:22-cv-01380-NLH-SAK Document 8-1 Filed 03/24/22 Page 6 of 16 PageID: 45Case 1:22-cv-01380-NLH-SAK Document 9 Filed 03/28/22 Page 6 of 16 PageID: 61
`
`
`
`
`
`
`
`
`
`
`
`F.
`
`iii.
`
`A copy of the Environmental Monitoring Program;
`
`Defendants shall destroy, under FDA supervision, all in-process and
`
`finished articles of pet food currently in their custody, control, or possession.
`
`
`
`
`
`G.
`
`Defendants recall, to the retail level and at their own expense, all pet food
`
`distributed since May 25, 2021, or Defendants provide documentation, to FDA’s satisfaction,
`
`showing that all products distributed since May 25, 2021 have been removed from the market.
`
`
`
`
`
`
`
`H.
`
`FDA, as it deems necessary to evaluate Defendants’ compliance with the
`
`terms of this Decree, the Act, and all applicable regulations, conducts inspections of the
`
`Defendants’ facility, including the buildings, sanitation-related systems, equipment, utensils, all
`
`articles of pet food, and relevant records contained therein;
`
`
`
`
`
`I.
`
`FDA notifies the Defendants in writing that Defendants appear to be in
`
`compliance with the requirements set forth in subparagraphs 6 (A)-(H) of this Decree, the Act,
`
`and the CGMP regulations at 21 C.F.R. Part 507;
`
`
`
`
`
`J.
`
`Defendants have paid all costs of inspection, analysis, review,
`
`investigations, examination, and supervision for FDA’s oversight with respect to paragraph 10,
`
`at the rates set forth in paragraph 14 below.
`
`
`
`7.
`
`Defendants and each and all of their directors, officers, agents, employees,
`
`representatives, successors, assigns, attorneys, and any and all persons in active concert or
`
`participation with any of them who receive notice of this Decree, are permanently restrained and
`
`enjoined under the provisions of 21 U.S.C.§332(a) from directly or indirectly doing or causing
`
`any act that:
`
`
`
`6
`
`

`

`
`
`Case 1:22-cv-01380-NLH-SAK Document 8-1 Filed 03/24/22 Page 7 of 16 PageID: 46Case 1:22-cv-01380-NLH-SAK Document 9 Filed 03/28/22 Page 7 of 16 PageID: 62
`
`
`
`
`
`A.
`
`violates the Act, 21 U.S.C. §331(a), by introducing, or delivering for
`
`introduction, into interstate commerce articles of pet food that are adulterated within the meaning
`
`of 21 U.S.C. §§ 342(a)(1) or (a)(4);
`
`
`
`
`
`B.
`
`violates the Act, 21 U.S.C. § 331(k), by causing articles of pet food to be
`
`adulterated within the meaning of 21 U.S.C. §§ 342(a)(1) or (a)(4) while such articles are held
`
`for sale after shipment of one or more ingredients in interstate commerce; or
`
`
`
`
`
`C.
`
`results in the failure to implement and continuously maintain the
`
`requirements of this Decree.
`
`
`
`8.
`
`Upon resuming operations after completing the requirements of paragraph 6, the
`
`Defendants shall continuously implement the following steps to prevent further Salmonella, L.
`
`mono, and other pathogenic microorganism contamination of their pet food products and facility:
`
`
`
`
`
`A.
`
`Effectively implement, on an ongoing basis, the Environmental
`
`Monitoring Program developed pursuant to paragraph 6(C), unless the Defendants submit, and
`
`FDA approves in writing, an alternative environmental monitoring program, consisting of
`
`validated methods and controls that are shown to FDA’s satisfaction to eliminate Salmonella, L.
`
`mono, and other pathogenic microorganisms in pet food. If in the event that the Defendants, the
`
`sanitation expert(s), or laboratory, determines that the Environmental Monitoring Program needs
`
`to be revised, the Defendants shall provide suggested changes to FDA in writing at least twenty
`
`(20) days prior to their implementation for the first three years after resuming pet food
`
`operations. After the first three years following resumption of pet food operations, Defendants
`
`shall maintain records of any modifications to the Environmental Monitoring Program that will
`
`be made available to FDA upon request.
`
`
`
`B.
`
`Conduct finished product testing in the following manner:
`
`7
`
`
`
`
`
`

`

`
`
`Case 1:22-cv-01380-NLH-SAK Document 8-1 Filed 03/24/22 Page 8 of 16 PageID: 47Case 1:22-cv-01380-NLH-SAK Document 9 Filed 03/28/22 Page 8 of 16 PageID: 63
`
`
`
`
`
`
`
`i.
`
`Immediately upon resumption of operations after the completion of
`
`the requirements of paragraph 6 (A)-(H), the Defendants shall test for Salmonella, L. mono, and
`
`speciate if isolated, in all lots of each finished pet food product for at least five consecutive
`
`production days using a sampling and testing method acceptable to FDA;
`
`
`
`
`
`
`
`ii.
`
`After the adequate completion of sampling and testing under the
`
`previous paragraph, the Defendants shall test at least one lot of each finished pet food product
`
`per day for the next twenty (20) production days;
`
`
`
`
`
`
`
`iii.
`
`After the adequate completion of sampling and testing under the
`
`previous subparagraph ii, the Defendants shall test at least one lot of each finished pet food
`
`product per every five (5) production days for the next three (3) months; and
`
`
`
`
`
`
`
`iv.
`
`After the adequate completion of sampling and testing under the
`
`previous paragraph, the Defendants shall test at least one lot of each finished pet food product
`
`per quarter thereafter.
`
`
`
`
`
`C.
`
`If any laboratory test completed pursuant to sub-paragraphs 8(B)(i)-(iii)
`
`shows the presence of Salmonella, L. mono, or other pathogenic microorganisms in finished pet
`
`food product, then the Defendants must immediately cease production and distribution of all pet
`
`food until they have determined and corrected the cause of the microbial contamination and take
`
`the following steps:
`
`
`
`
`
`
`
`i.
`
`The Defendants shall notify the FDA within two (2) business days
`
`of receiving a laboratory report of a presumptive positive test result;
`
`
`
`
`
`
`
`ii.
`
`Finished products found to contain Salmonella, L. mono, or other
`
`pathogenic microorganisms cannot be reconditioned and resold as finished raw pet food. Such
`
`contaminated products shall be either be destroyed after FDA notification or directed to a process
`
`
`
`8
`
`

`

`
`
`Case 1:22-cv-01380-NLH-SAK Document 8-1 Filed 03/24/22 Page 9 of 16 PageID: 48Case 1:22-cv-01380-NLH-SAK Document 9 Filed 03/28/22 Page 9 of 16 PageID: 64
`
`that will inactivate the pathogens (e.g., rendering). Defendants must submit a written plan for
`
`any process that will inactivate pathogens to FDA and receive written approval of the plan from
`
`FDA before beginning the process;
`
`
`
`
`
`
`
`iii.
`
`Any environmental samples or pet food products found to be
`
`positive for Salmonella, L. mono, or other pathogenic microorganisms through laboratory
`
`analysis shall be made available to the FDA, upon request, for further analysis;
`
`
`
`
`
`
`
`iv.
`
`Once the cause of the contamination has been corrected, the
`
`Defendants shall reinstate the complete sequence of testing under paragraph 8 anew.
`
`
`
`9.
`
`If, after notifying FDA of the name of the laboratory retained to conduct sample
`
`collection and analysis pursuant to paragraph 6(A), Defendants terminate or alter their service
`
`contract with the laboratory in any way, Defendants shall notify FDA within five (5) business
`
`days. Defendants shall contract with a new laboratory for collection and analysis services
`
`promptly, and Defendants shall provide a copy of the new service contract to FDA within five
`
`(5) business days of execution.
`
`
`
`
`
`10.
`
`FDA shall be permitted, without prior notice and as and when FDA deems
`
`necessary, to make inspections of Defendants’ facility and, without prior notice, take any other
`
`measures necessary to monitor and ensure continuing compliance with the terms of this Decree,
`
`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; to take photographs and make video recordings; to
`
`take samples of Defendants’ raw ingredients, in-process and finished articles of food, containers,
`
`and packaging material; and to examine and copy all records related to receiving, processing,
`
`manufacturing, preparing, packing, holding, and/or distributing any and all articles of food. The
`
`
`
`9
`
`

`

`
`
`Case 1:22-cv-01380-NLH-SAK Document 8-1 Filed 03/24/22 Page 10 of 16 PageID: 49Case 1:22-cv-01380-NLH-SAK Document 9 Filed 03/28/22 Page 10 of 16 PageID: 65
`
`inspections shall be permitted upon presentation of a copy of this Decree and appropriate
`
`credentials. The inspection authority granted by this Decree is apart from, and in addition to, the
`
`authority to make inspections under the Act, 21 U.S.C. § 374.
`
`
`
`11.
`
`Defendants shall immediately provide any information or records to FDA, upon
`
`request, regarding the receipt, preparation, processing, packing, holding, or distribution of pet
`
`food. Defendants shall maintain a copy of all records required by 21 C.F.R. Part 507 at the
`
`facility in a location where they are readily available for reference and inspection by FDA
`
`representatives. All records required to be kept by 21 C.F.R. Part 507 shall be retained for at
`
`least two (2) years after the date they are prepared and shall be presented immediately to FDA
`
`investigators upon request.
`
`
`
`12.
`
`If, at any time after this entry of this Decree, FDA determines, based on the
`
`results of an inspection, the analysis of a sample, report or data prepared or submitted by
`
`Defendants or the sanitation expert, or any other information, that Defendants have failed to
`
`comply with any provision of this Decree, have violated the Act or its implementing regulations,
`
`or that additional corrective actions are necessary to achieve compliance with this Decree, the
`
`Act, or its applicable regulations, FDA may, as and when it deems necessary, notify Defendants
`
`in writing of the noncompliance and order Defendants to take appropriate corrective action,
`
`including, but not limited to, ordering Defendants to immediately take one or more of the
`
`following actions:
`
`
`
`
`
`A.
`
`Cease preparing, manufacturing, processing, packing, holding, and/or
`
`distributing any and all articles of animal food;
`
`
`
`
`
`B.
`
`Recall, at Defendants’ expense, any and all articles of animal food that
`
`have been distributed and/or are under the custody and control of Defendants’ agents,
`
`
`
`10
`
`

`

`
`
`Case 1:22-cv-01380-NLH-SAK Document 8-1 Filed 03/24/22 Page 11 of 16 PageID: 50Case 1:22-cv-01380-NLH-SAK Document 9 Filed 03/28/22 Page 11 of 16 PageID: 66
`
`distributors, customers, or consumers that in FDA’s judgment is adulterated or otherwise in
`
`violation of this Decree, the Act, or its implementing regulations;
`
`
`
`
`
`C.
`
`Revise, modify, expand, or continue to submit any reports or plans
`
`prepared pursuant to this Decree;
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`D.
`
`E.
`
`F.
`
`G.
`
`H.
`
`Submit additional reports or information to FDA as requested;
`
`Submit samples to a qualified laboratory for analysis;
`
`Institute or reimplement any of the requirements set forth in this Decree;
`
`Issue a safety alert; and/or
`
`Take any other corrective actions as FDA, in its discretion, deems
`
`necessary to protect the public health or bring Defendants into compliance with this Decree, the
`
`Act, or its implementing regulations.
`
`This remedy shall be separate and apart from, and in addition to, any other remedy available to
`
`the United States under this Decree or under the law.
`
`
`
`13.
`
`Upon receipt of any order issued by FDA pursuant to paragraph 12, Defendants
`
`shall immediately and fully comply with the terms of the order. Any cessation of operations or
`
`other action described in paragraph 12 shall continue until Defendants receive written
`
`notification from FDA that Defendants appear to be in compliance with this Decree, the Act, and
`
`its implementing regulations, and that Defendants may resume operations. The cost of FDA
`
`inspections, investigations, supervision, examinations, sampling, testing, travel time, and
`
`subsistence expenses to implement and monitor the remedies set forth in this paragraph shall be
`
`borne by Defendants at the rates specified in paragraph 14.
`
`
`
`14.
`
`Defendants shall pay all costs of FDA’s supervision, inspections, investigations,
`
`analyses, examinations, and reviews that FDA deems necessary to evaluate Defendants’
`
`
`
`11
`
`

`

`
`
`Case 1:22-cv-01380-NLH-SAK Document 8-1 Filed 03/24/22 Page 12 of 16 PageID: 51Case 1:22-cv-01380-NLH-SAK Document 9 Filed 03/28/22 Page 12 of 16 PageID: 67
`
`compliance with this Decree, at the standard rates prevailing at the time the costs are incurred.
`
`As of the date that this Decree is signed by the parties, these rates are: $102.39 per hour or
`
`fraction thereof per representative for inspection and investigative work; $122.71 per hour or
`
`fraction thereof per representative for analytical or review work; $0.56 per mile for travel
`
`expenses by automobile; government rate or the equivalent for travel by air or other means; and
`
`the published government per diem rate 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.
`
`
`
`15.
`
`If any Defendant violates this Decree and is found in civil or criminal
`
`contempt thereof, Defendants shall, in addition to other remedies, reimburse Plaintiff for its
`
`attorneys’ fees (including overhead), 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 contempt proceedings.
`
`
`
`16. Defendants shall abide by the decisions of FDA, and FDA’s decisions shall be
`
`final. All decisions conferred upon FDA in this Decree shall be vested in FDA’s discretion and,
`
`if contested, shall be reviewed by this 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
`
`Decree shall be based exclusively on the written record before FDA at the time the decision was
`
`made. No discovery shall be taken by either party.
`
`
`
`
`
`17. Within ten (10) calendar days after entry of this Decree, Defendants shall:
`
`
`
`A.
`
`provide a copy of this Decree by personal service or certified mail
`
`(restricted delivery, return receipt requested), to each and all of their directors, officers, agents,
`
`representatives, employees, attorneys, successors, assigns, and any and all persons in active
`
`
`
`12
`
`

`

`
`
`Case 1:22-cv-01380-NLH-SAK Document 8-1 Filed 03/24/22 Page 13 of 16 PageID: 52Case 1:22-cv-01380-NLH-SAK Document 9 Filed 03/28/22 Page 13 of 16 PageID: 68
`
`concert or participation with any of them (including individuals, directors, partnerships,
`
`corporations, subsidiaries, and affiliates);
`
`
`
`
`
`B.
`
`prominently post a copy of this Decree in an employee common area at
`
`Defendants’ facility and ensure that this Decree remains posted so long as it remains in effect;
`
`and
`
`
`
`
`
`C.
`
`hold a meeting for their employees, at which Defendants shall describe the
`
`terms and obligations of this Decree, provided Defendant has employees that are receiving,
`
`preparing, manufacturing, processing, packing, holding, and/or distributing pet food; at the time
`
`of entry of this Decree.
`
`
`
`18. Within twenty (20) calendar days after entry of this Decree, Defendants shall
`
`provide FDA with an affidavit of compliance with paragraph 17, stating the fact and manner of
`
`compliance and identifying the names and positions of all persons so notified.
`
`
`
`19.
`
`After entry of this Decree, in the event that any Defendant becomes associated
`
`with any additional directors, officers, agents, representative, employees, attorneys, successors,
`
`assigns, or any additional persons in active concert or participation with any of them (including,
`
`individuals, directors, partnerships, corporations, subsidiaries, and affiliates) that are engaged in
`
`manufacturing, processing, preparing, packing, holding, or distributing food at any time after
`
`entry of this Decree, Defendants shall immediately provide a copy of this Decree, by personal
`
`service or certified mail (restricted delivery, return receipt requested), to such persons. Within
`
`ten (10) calendar days after each instance that Defendant becomes associated with any individual
`
`persons, Defendants shall provide to FDA an affidavit stating the fact and manner of Defendants’
`
`compliance with this paragraph, identifying the names, addresses, and positions of all persons
`
`who received a copy of this Decree pursuant to this paragraph, and attaching a copy of the
`
`
`
`13
`
`

`

`
`
`Case 1:22-cv-01380-NLH-SAK Document 8-1 Filed 03/24/22 Page 14 of 16 PageID: 53Case 1:22-cv-01380-NLH-SAK Document 9 Filed 03/28/22 Page 14 of 16 PageID: 69
`
`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 Defendants’
`
`compliance with this paragraph, Defendants shall provide such information or documentation to
`
`FDA.
`
`
`
`20.
`
`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 Decree. Defendants shall provide any prospective successor or assign with a
`
`copy of this Decree 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 Decree to a prospective successor or assign.
`
`
`
`21.
`
`Defendants shall address all communications required under this Decree to the
`
`Human & Animal Food Division II East, New Jersey District Office, 10 Waterview Boulevard,
`
`Parsippany, New Jersey 07054, with a copy to orahafeast2firmresponses@fda.hhs.gov.
`
`Defendants shall prominently mark the envelope, and the email copy, as “DECREE
`
`CORRESPONDENCE,” and shall reference this civil action by case name and civil action
`
`number.
`
`
`
`22.
`
`The parties may at any time petition each other in writing to modify any deadline
`
`provided herein and if the parties mutually agree in writing to modify a deadline, such
`
`modification may be granted and may become effective without leave of the Court.
`
`
`
`14
`
`

`

`Case 1:22-cv-01380-NLH-SAK Document 9 Filed 03/28/22 Page 15 of 16 PageID: 70
`
`CGéaseli227enr00BBSONIIEFSSAK Docommeent®91 Ailtelc0G2234222 FaagelSoobflberageellD 774
`
`23. This Court retams jurisdiction of this action for the purpose of enforemg or modifying
`
`this Decree and for the purpose of grantmg such additional relief as may be necessary or
`
`appropriate.
`
`24.|Nosooner than five (5) years after entry of this Decree, Defendants may petition
`
`this Court for an order dissolving this Decree. If Defendants have mamtamed,
`
`to FDA’s
`
`satisfaction, a state of compliance with this Decree, the Act, and all applicable regulations for
`
`five (5) years precedmg Defendant’s petition,
`
`the United States will not oppose such petition.
`
`SO ORDEREDthis 28th day of March, 2022.
`
`s/ Noel L. Hillman
`
`UNITED STATES DISTRICT JUDGE
`
`15
`
`

`

`
`
`Case 1:22-cv-01380-NLH-SAK Document 8-1 Filed 03/24/22 Page 16 of 16 PageID: 55Case 1:22-cv-01380-NLH-SAK Document 9 Filed 03/28/22 Page 16 of 16 PageID: 71
`
`