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`BRIANNA GARDNER
`SARAH WILLIAMS
`Trial Attorneys
`Consumer Protection Branch
`U.S. Department of Justice, Civil Division
`PO Box 386
`Washington, DC 20044-0386
`202-532-4786 (Gardner)
`202-616-4269 (Williams)
`Fax: 202-514-8742
`Brianna.m.gardner@usdoj.gov
`sarah.williams@usdoj.gov
`
`Counsel for Plaintiff
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`
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`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEVADA
`
`
`UNITED STATES OF AMERICA,
`
` Plaintiff,
`
`v.
`
`AFFINITYLIFESTYLES.COM, INC., and
`REAL WATER, INC., corporations, and
`BRENT A. JONES and BLAIN K. JONES,
`individuals,
`
` Defendants.
`
`
`
`Case No. __________________
`
`
`
`
`
`CONSENT DECREE OF PERMANENT
`INJUNCTION
`
`
`
`
`
`Plaintiff, the United States of America, on behalf of the United States Food and Drug
`Administration (“FDA”), by its undersigned attorneys, having filed a Complaint for Injunction
`(“Complaint”) against Affinitylifestyles.com, Inc., and Real Water, Inc., corporations; and Brent
`A. Jones and Blain K. Jones, individuals (collectively, “Defendants”), and Defendants having
`appeared and having consented to the entry of this Consent Decree of Permanent Injunction (the
`“Decree”) without contest and without admitting the violations described herein, 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 as follows:
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`21-cv-959-JAD-BNW
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`ECF No. 3
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`

`

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`1. This Court has jurisdiction over the subject matter and all parties to this action.
`2. The Complaint states a cause of action against Defendants under the Federal Food,
`Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq. (the “Act”).
`3. Defendants violated 21 U.S.C. § 331(uu), by operating a facility that manufactured,
`processed, packed, or held food for sale in the United States, and not doing so in compliance
`with the hazard analysis and risk-based preventive controls requirements in 21 U.S.C. § 350g.
`4. Defendants violated 21 U.S.C. § 331(a), by introducing or delivering for introduction
`into interstate commerce, or causing to be introduced or delivered for introduction into interstate
`commerce, articles of food that were adulterated 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 whereby they may have been rendered injurious to
`health.
`
`5. Defendants violated 21 U.S.C. § 331(k), by causing articles of food that were held for
`sale after shipment of one or more of their components in interstate commerce to become
`adulterated under 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 whereby they
`may have been rendered injurious to health.
`6. Defendants violated 21 U.S.C. § 331(a), by introducing or delivering for introduction
`into interstate commerce, or causing to be introduced or delivered for introduction into interstate
`commerce, articles of food that were misbranded within the meaning of 21 U.S.C. § 343(i)(2).
`7. Defendants violated 21 U.S.C. § 331(k), by causing articles of food that were held for
`sale after shipment of one or more of their components in interstate commerce to become
`misbranded within the meaning of 21 U.S.C. § 343(i)(2).
`8. For the purposes of this Decree, the following definitions shall apply:
`A. “Defendants’ Facilities” mean the facilities located at 1180 Center Point Drive,
`Suite 200, Henderson, Nevada, and 6018 E. Main Street, Mesa, Arizona, and/or any other
`location(s) at which Defendants now or in the future directly or indirectly manufacture, process,
`prepare, bottle, pack, label, hold, and/or distribute any article of food; and
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`B. “Defendants’ Products” shall refer to Defendants’ “Re2al Water Drinking Water”
`and “Re2al Alkalized Water” bottled drinking water (together, “Re2al Water”) and “Re2al
`Alkalized Water Concentrate” chemical concentrate (“E2 Concentrate”), as well as any other
`article of food that Defendants now or in the future directly or indirectly manufacture, process,
`prepare, bottle, pack, label, hold, and/or distribute; and
`C. “CGMP” shall refer to current good manufacturing practice requirements for
`human food (set forth at 21 C.F.R. Part 117, Subpart B) and bottled drinking water (set forth at
`21 C.F.R. Part 129).
`9. Upon entry of this Decree, Defendants and each and all 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 (including individuals, partnerships,
`corporations, subsidiaries, affiliates, and “doing business as” entities) (collectively, “Associated
`Persons”) who have received 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 manufacturing, processing, preparing, bottling,
`packing, labeling, holding, and/or distributing articles of food at or from Defendants’ Facilities
`unless and until:
`A. Defendants retain, at Defendants’ expense, an independent person or persons (the
`“Food Safety & Preventive Controls (‘PC’) Expert”) who is without any personal or financial
`ties (other than the retention agreement) to Defendants or their families, who meets the
`requirements of a preventive controls qualified individual (“PCQI”) as defined in 21 C.F.R. §
`117.3, and who, by reason of background, training, education, and experience, is qualified: (1) to
`establish methods, processes, and controls at Defendants’ Facilities to ensure that articles of food
`are manufactured, processed, prepared, bottled, packed, labeled, held, and distributed in
`compliance with CGMP; (2) to develop and implement a written Sanitation Plan, a Bottling Plan,
`and a Food Safety Plan in accordance with 9(B) below; and (3) to inspect Defendants’ Facilities
`to determine whether Defendants’ methods, processes, and controls are continuously operated
`and administered in conformity with this Decree, the Act, and its implementing regulations.
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`Defendants shall notify FDA in writing of the identity and qualifications of the Food Safety &
`PC Expert within two (2) business days after retaining such Food Safety & PC Expert; and
`B. The Food Safety & PC Expert, in conjunction with Defendants:
`(1) Review all FDA inspectional observations of deficiencies at Defendants’
`Facilities from March/April 2021 to the present and develop, to FDA’s satisfaction:
`a. A written Sanitation Plan and Sanitation Standard Operating Procedures
`(hereafter, “Sanitation Plan”) for manufacturing, processing, preparing, packing, holding, and
`distributing articles of food. Such Sanitation Plan shall ensure that Defendants’ manufacturing
`processes, cleaning and sanitizing operations, monitoring, and corrective actions, protect against
`the contamination of food and food-contact surfaces and prevent insanitary conditions at
`Defendants’ Facilities, and shall address, but not be limited to, contamination by chemical
`hazards and environmental pathogens; and
`b. A written Bottled Water Processing & Bottling Plan (hereafter, “Bottling
`Plan”) for processing, bottling, and holding of bottled drinking water. Such Bottling Plan shall
`ensure that Defendants’ manufacturing and bottling processes, cleaning and sanitizing
`operations, sampling and sampling analysis, monitoring, and corrective actions, comply with
`applicable standards, protect against the contamination of bottled drinking water and water-
`contact surfaces, and prevent insanitary conditions at Defendants’ Facilities, and shall address,
`but not be limited to, contamination by chemical hazards and environmental pathogens; and
`(2) Ensure that Defendants adhere to the Act, the Current Good Manufacturing
`Practice, Hazard Analysis and Risk-Based Preventive Controls for Human Food Rule (“Food
`CGMP & PC Rule”), 21 C.F.R. Part 117, and the Processing and Bottling of Bottled Drinking
`Water Rule (“Bottled Water CGMP Rule”), 21 C.F.R. Part 129; and
`(3) Conduct a hazard analysis of all foods manufactured by Defendants and
`develop, to FDA’s satisfaction, a written Food Safety Plan identifying required preventive
`controls for Defendants’ Products and manufacturing processes consistent with the Food CGMP
`& PC Rule and the Bottled Water CGMP Rule, and establishing adequate measures to control for
`all hazards requiring preventive controls consistent with 21 C.F.R. Part 117 Subpart C and
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`associated subparts; and
`(4) Develop, to FDA’s satisfaction, a written employee training program (in English
`and any other language necessary to convey the substance of the training), addressing the Food
`CGMP & PC Rule, the Bottled Water CGMP Rule, the Sanitation Plan, the Bottling Plan, and
`the Food Safety Plan approved by FDA under paragraph 9(C), and after receiving FDA’s
`approval of such program in accordance with paragraph 9(C), train Defendants and their officers,
`employees, and all other persons who perform duties at Defendants’ Facilities in accordance with
`such program, which shall include, but not be limited to, maintaining sanitation, conducting
`adequate sampling and analysis, avoiding microbial contamination, and controlling chemical
`hazards and environmental pathogens; and(5) Submit to FDA documentation demonstrating that
`the Food Safety & PC Expert has adequately trained Defendants and their officers, employees,
`and all other persons who perform duties at Defendants’ Facilities; and
`C. FDA has approved, in writing, the Sanitation Plan, Bottling Plan, Food Safety
`Plan, and employee training program developed by the Expert, as specified in paragraph 9(B);
`and
`
`D. Defendants:
`(1) Assign continuing responsibility for implementing and monitoring the
`Sanitation Plan and the Bottling Plan to a person(s) who is trained in processing and bottled
`drinking water requirements, see 21 C.F.R. Part 129, and who, by reason of background,
`education, training, or experience, is qualified to maintain Defendants’ Facilities in a sanitary
`condition, coordinate and implement any necessary corrective actions, and who meets the
`requirements of a PCQI as defined in 21 C.F.R. §117.3, and Defendants provide such person
`with the authority and resources to achieve any necessary corrective action; and
`(2) Ensure that the FDA-approved Sanitation Plan, Bottling Plan and Food Safety
`Plan are available and accessible (in English and any other language necessary to convey the
`substance of such documents) to their officers, employees, and all other persons who perform
`duties at Defendants’ Facilities; and
`(3) Successfully complete the FDA-approved employee training program; and
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`(4) Destroy, under FDA’s supervision, and in accordance with the procedures in
`paragraph 11, all articles of food and food ingredients (including but not limited to in-process
`and finished articles of food), as well as all unused labels and empty labeled bottles, in
`Defendants’ custody, control, or possession as of the date this Decree is signed by the parties;
`and
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`(5) At their expense, clean and sanitize Defendants’ Facilities and equipment
`therein to render Defendants’ Facilities and equipment suitable for manufacturing, processing,
`preparing, bottling, packing, labeling, holding, and distributing articles of food in accordance
`with this Decree, the Act, and its implementing regulations, and ensure that Defendants’
`Facilities and equipment therein will be continuously maintained in a sanitary condition; and
`E. The Food Safety & PC Expert conducts a comprehensive inspection of
`Defendants’ Facilities and the methods, processes, and controls used to manufacture, process,
`prepare, bottle, pack, label, hold, and/or distribute articles of food and certifies in writing to FDA
`that: (1) he or she has inspected Defendants’ Facilities, and the methods, processes, and controls
`used to manufacture, process, prepare, bottle, pack, label, hold, and distribute articles of food; (2)
`Defendants have corrected all the deficiencies observed by FDA during FDA’s March/April
`2021 inspections, specifying each FDA inspectional observation and Defendants’ corrections
`thereof; and (3) Defendants’ Facilities and the methods, processes, and controls used to
`manufacture, process, prepare, bottle, pack, label, hold, and distribute articles of food are, in the
`Food Safety & PC Expert’s opinion, in compliance with this Decree (including the written
`Sanitation Plan, Bottling Plan, and Food Safety Plan), the Act, and its implementing regulations,
`including but not limited to the Food CGMP & PC Rule and the Bottled Water CGMP Rule.
`Defendants shall ensure that the Food Safety & PC Expert’s written certification contains a
`detailed report of the Food Safety & PC Expert’s inspectional findings and includes, but is not
`limited to, a determination that Defendants have implemented procedures that are adequate to
`ensure continuing compliance with the Sanitation Plan, Bottling Plan, Food Safety Plan, the
`Food CGMP & PC Rule, and the Bottled Water CGMP Rule. Defendants shall also ensure that
`the Food CGMP & PC Expert’s written certification with supporting documentation is submitted
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`to Defendants and FDA concurrently, within ten (10) business days after completing the
`inspection; and
`F. Defendants retain, at Defendants’ expense, an independent person (the “Labeling
`Expert”) who is without any personal or financial ties (other than a retention agreement) to
`Defendants or their families, except that this person may be the same as the Food Safety & PC
`Expert, and who, by reason of background, training, education, or experience, is qualified to
`review Defendants’ product labeling to determine whether it complies with 21 U.S.C. § 343 and
`all applicable regulations. Defendants shall notify FDA in writing of the identity and
`qualifications of the Labeling Expert within three (3) business days after retaining such Labeling
`Expert; and
`G. The Labeling Expert performs a comprehensive review of Defendants’ product
`labeling and certifies in writing to FDA that: (1) he or she has reviewed Defendants’ product
`labeling; (2) all deviations from 21 U.S.C. § 343 and applicable regulations that have been
`brought to Defendants’ attention by FDA, the Labeling Expert, and any other source, have been
`corrected; and (3) Defendants’ product labeling is, in the Labeling Expert’s opinion, in
`compliance with this Decree, the Act, and its implementing regulations. Defendants shall ensure
`that the Labeling Expert’s written certification contains a detailed report of the Labeling Expert’s
`review that includes, but is not limited to, samples of all reviewed product labels and a
`determination that Defendants have implemented procedures that are adequate to ensure that
`their labeling complies with 21 U.S.C. § 343 and all applicable regulations. Defendants shall also
`ensure that the Labeling Expert’s written certification with supporting documentation is
`submitted to Defendants and FDA concurrently, within ten (10) business days after completing
`the labeling review; and
`H. Defendants recall and destroy, under FDA’s supervision and in accordance with
`the procedures provided in paragraphs 10-11, all of Defendants’ Re2al Water and E2
`Concentrate that were manufactured, processed, prepared, bottled, packed, labeled, held, and/or
`distributed by Defendants through and including the date of entry of this Decree; and
`I. FDA, as it deems necessary to evaluate Defendants’ compliance with the terms of
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`this Decree, the Act, and its implementing regulations, including but not limited to the Food
`CGMP & PC Rule and the Bottled Water CGMP Rule, inspects Defendants’ Facilities, including
`the buildings, sanitation-related systems, equipment, utensils, and all articles of food and relevant
`records contained therein; and
`J. FDA notifies Defendants in writing that Defendants appear to be in compliance
`with the requirements set forth in paragraphs 9(A) – 9(H) of this Decree, the Act, and its
`implementing regulations. In no circumstance shall FDA’s silence be construed as a substitute
`for written notification.
`10. Within three (3) business days after entry of this Decree, Defendants shall submit to
`FDA for review and written concurrence a plan to recall Defendants’ Products identified in
`paragraph 9(H). The recall plan shall include customer notifications, public warning, methods for
`conducting effectiveness checks, and plans for product disposition. Within five (5) business days
`after receiving FDA concurrence on the recall plan, Defendants shall initiate a recall pursuant to
`the recall plan.
`11. Within fifteen (15) business days after completing the recall of all Defendants’
`Products identified in paragraph 9(H), Defendants shall give notice to FDA that, under FDA’s
`supervision, Defendants are prepared to destroy all Defendants’ Products identified in paragraph
`9(H) in Defendants’ possession, custody, or control. Defendants’ notice shall specify the
`proposed time, place, and method of destruction. Defendants shall not commence or permit any
`other person to commence destruction until they have received written authorization from FDA
`to commence the destruction. Within fifteen (15) business days after receiving authorization
`from FDA to commence destruction, Defendants shall, under FDA supervision, complete the
`destruction in compliance with this Decree. Defendants shall not dispose of any such products in
`a manner contrary to the provisions of the Act, any other federal law, any court order, or the laws
`of any state or Territory, as defined in the Act, in which the products are disposed. Defendants
`shall bear all costs of destruction and FDA’s supervision.
`12. Upon resuming operations after complying with paragraph 9 and receiving FDA’s
`written notification pursuant to paragraph 9(J), Defendants shall meet the following
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`requirements:
`A. Defendants shall continuously and effectively implement, on an ongoing basis, the
`Sanitation Plan, Bottling Plan, and the Food Safety Plan, and employee training program
`developed pursuant to paragraph 9(B) and approved by FDA pursuant to paragraph 9(C), which
`training program shall be completed by each new employee within five (5) business days after
`the new employee commences duties at Defendants’ Facilities, and shall include ongoing
`training programs for employees; and
`B. Defendants shall retain an independent person or persons (the “Auditor”) who
`shall meet the criteria for and may be the same person as the Food Safety & PC Expert and
`Labeling Expert(s) described in paragraphs 9(A) and 9(F), to conduct audit inspections of
`Defendants’ Facilities and the methods, processes, and controls used to manufacture, process,
`prepare, bottle, pack, label, hold, or distribute articles of food, and of Defendants’ product
`labeling, as follows:
`(1) Within thirty (30) business days after Defendants resume their operations after
`completing the requirements in paragraph 9, the Auditor shall conduct an audit of Defendants’
`Facilities and the methods and controls used to manufacture, process, prepare, bottle, pack, label,
`hold, and distribute articles of food to determine whether Defendants are operating in compliance
`with this Decree, the Act, and its implementing regulations, and to identify any deviations from
`such requirements. The Auditor shall submit an Audit Report documenting all findings to
`Defendants and FDA concurrently, within seven (7) business days after completing the audit;
`and
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`(2) Thereafter, the Auditor shall conduct audits no less frequently than once every
`(3) months for a period of no less than one (1) year, and then at least once every six (6) months
`for the next two (2) years. Beginning in the fourth year after Defendants resume their operations
`after completing the requirements of paragraph 9, the Auditor shall conduct audits at least
`annually unless FDA informs Defendants in writing that more frequent audit inspections and
`reporting are required. If any Audit Report identifies any deviation from this Decree, the Act, or
`its implementing regulations, FDA, in its discretion, may require the audit cycle to begin anew;
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`and
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`(3) As part of every Audit Report (except the first one), the Auditor shall assess
`adequacy of actions taken by Defendants to correct all previous audit observations indicating that
`Defendants are not in compliance with this Decree, the Act, or its implementing regulations. If
`the Audit Report contains any audit observations indicating that Defendants are not in
`compliance with this Decree, the Act, or its implementing regulations, Defendants shall make all
`necessary corrections within ten (10) business days after receipt of the Audit Report, unless FDA
`notifies Defendants in writing that a shorter time period is necessary; and
`(4) Within twenty (20) business days after the required completion date for any
`corrective action under paragraph 12(B)(3), the Auditor shall review each and all corrective
`action(s) taken by Defendants and report in writing to FDA whether each deviation listed in the
`Audit Report has been corrected.
`13. Upon entry of this Decree, and after Defendants receive notification under paragraph
`9(J) from FDA that they are permitted to resume operations, Defendants and all Associated
`Persons, are permanently restrained and enjoined under 21 U.S.C. § 332(a) from directly or
`indirectly doing or causing to be done any of the following acts:
`A. Violating 21 U.S.C. § 331(uu), by operating a facility that manufactures,
`processes, packs, or holds food for sale in the United States, and not doing so in compliance with
`the hazard analysis and risk-based preventive controls requirements in 21 U.S.C. § 350g; and
`B. Violating 21 U.S.C. § 331(a), by introducing or delivering for introduction into
`interstate commerce, or causing the introduction or delivery for introduction into interstate
`commerce, articles of food that are adulterated within the meaning of 21 U.S.C. § 342(a)(4)
`and/or misbranded within the meaning of 21 U.S.C. § 343; and
`C. Violating 21 U.S.C. § 331(k), by causing articles of food that are held for sale after
`shipment in interstate commerce to become adulterated within the meaning of 21 U.S.C. §
`342(a)(4) and/or misbranded within the meaning of 21 U.S.C. § 343; and
`D. Failing to implement and continuously maintain the requirements of the Act, its
`implementing regulations, and this Decree.
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`14. 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, the
`Food Safety & PC Expert, the Labeling Expert, the Auditor, 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 manufacturing, processing, preparing, bottling, packing, labeling, holding,
`and/or distributing any and all articles of food;
`B. Recall, at Defendants’ expense, any and all articles of food that have been
`distributed and/or are under the custody and control of Defendants’ agents, distributors,
`customers, or consumers that in FDA’s judgment is adulterated, misbranded, 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. Submit additional reports or information to FDA as requested;
`E. Submit samples to a qualified laboratory for analysis;
`F. Institute or reimplement any of the requirements set forth in this Decree;
`G. Issue a safety alert; and/or
`H. 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.
`15. Upon receipt of any order issued by FDA pursuant to paragraph 14, Defendants shall
`immediately and fully comply with the terms of the order. Any cessation of operations or other
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`action described in paragraph 14 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 18.
`16. Representatives of FDA shall be permitted, without prior notice and as and when
`FDA deems necessary, to inspect Defendants’ Facilities, collect samples, and, without prior
`notice, take any other measures necessary to monitor and ensure continuing compliance with the
`terms of this Decree, the Act, and all applicable regulations. During such inspections, FDA
`representatives shall be permitted: immediate access to Defendants’ Facilities and/or other
`place(s) of business, including but not limited to all buildings or other structures, equipment, raw
`ingredients, in-process or unfinished and finished materials and products, and containers; to take
`photographs and make video recordings; to take samples of Defendants’ raw ingredients,
`finished and unfinished materials and products, and containers; and examine and copy all records
`relating to the receipt, holding, and distribution of any and all of Defendants’ Products and their
`components. The inspections shall be permitted upon presentation of a copy of this Decree and
`appropriate credentials. The inspection authority granted by this Decree is separate and apart
`from, and in addition to, the authority to make inspections under the Act, 21 U.S.C. § 374.
`17. Defendants shall promptly provide any information or records to FDA upon request
`regarding the manufacturing, processing, preparing, bottling, packing, labeling, holding, and/or
`distributing of Defendants’ Products. Defendants shall maintain copies of their Sanitation Plan,
`Bottling Plan, and their Food Safety Plan, along with copies of all records required by such plans
`and this Decree, at Defendants’ Facilities, in a location where the records are readily available
`for reference and inspection by FDA. Defendants shall retain all records referred to in this
`paragraph for at least three (3) years after the date the records are prepared.
`18. Defendants shall pay all costs of FDA’s inspections, investigations, supervision,
`analyses, examinations, and reviews that FDA deems necessary to evaluate Defendants’
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`compliance with any part of this Decree, including all transportation and associated costs for
`FDA investigators and experts, at the standard rates prevailing at the time the costs are incurred.
`As of the date of entry of this Decree, 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.
`19. Within five (5) business days after the entry of this Decree, Defendants shall post a
`copy of this Decree in a common area at Defendants’ Facilities and at any other location at
`which Defendants conduct business and shall ensure that this Decree remains posted for as long
`as this Decree remains in effect. Within ten (10) business days after entry of this Decree,
`Defendants shall provide to FDA an affidavit, from a person with personal knowledge of the
`facts stated therein, stating the fact and manner of compliance with this paragraph.
`20. Within ten (10) business days after the entry of this Decree, Defendants shall provide
`a copy of this Decree by personal service or certified mail (return receipt requested) to each and
`all Associated Persons. Within twenty (20) business days after the date of entry of this Decree,
`Defendants shall provide to FDA an affidavit stating the fact and manner of their compliance
`with this paragraph, including identifying the names, addresses, and positions of all Associated
`Persons who have received a copy of this Decree pursuant to this paragraph.
`21. In the