Case 1:20-cv-03191-SAB ECF No. 3 filed 01/14/21 PageID.43 Page 1 of 17
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`UNITED STATES DISTRICT COURT
`EASTERN DISTRICT OF WASHINGTON
`
`UNITED STATES OF AMERICA,
`
`Plaintiff,
`
`v.
`
`VALLEY PROCESSING, INC.,
`a corporation, and MARY ANN
`BLIESNER, individually,
`
`Defendants.
`
`-SAB
`Civil Action No. 1:20-cv-3191
`
`CONSENT DECREE OF
`PERMANENT INJUNCTION
`
` Plaintiff, the United States of America, by its undersigned attorneys, having filed
`
`a Complaint for Permanent Injunction against Valley Processing, Inc. (“Valley
`
`Consent Decree of Permanent Injunction
`
` 1
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`FILED IN THE
`U.S. DISTRICT COURT
`EASTERN DISTRICT OF WASHINGTON
`
`SEAN F. MCAVOY, CLERK
`
`Jan 14, 2021
`
`

`

`Case 1:20-cv-03191-SAB ECF No. 3 filed 01/14/21 PageID.44 Page 2 of 17
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`Processing”) and Mary Ann Bliesner, (collectively, “Defendants”), and Defendants
`
`having appeared and consented to the entry of this Consent Decree of Permanent
`
`Injunction (“Decree”) without contest 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:
`
`1. This Court has jurisdiction over the subject matter and over all parties to this
`
`action.
`
`2. The Complaint for Permanent 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. Defendants violate the Act, 21 U.S.C. § 331(a), by introducing or delivering for
`
`introduction into interstate commerce, or the causing thereof, articles of food within the
`
`meaning of 21 U.S.C. § 321(f), namely single strength fruit juice and fruit juice
`
`concentrate, including bulk apple, pear, and grape juice products (“juice products”) that
`
`are adulterated, in violation of 21 U.S.C. § 331(a).
`
`4. Defendants violate the Act, 21 U.S.C. § 331(k), by causing the adulteration of
`
`articles of food while such articles are held for sale after shipment of one or more
`
`components in interstate commerce.
`
`5. The articles of food are 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 rendered injurious to health.
`
`Consent Decree of Permanent Injunction
`
` 2
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`

`

`Case 1:20-cv-03191-SAB ECF No. 3 filed 01/14/21 PageID.45 Page 3 of 17
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`6. The articles of food are also adulterated within the meaning of 21 U.S.C. §
`
`342(a)(3) in that the food “consists in whole or in part of any filthy, putrid, or
`
`decomposed substance, or if it is otherwise unfit for food.”
`
`7. Defendants represent to the Court that, with the exception of holding and
`
`shipping product for destruction pursuant to paragraph 9, at the time of entry of this
`
`Decree, they are not engaged in processing, manufacturing, preparing, packing, holding,
`
`or distributing any type of food. With the exception of any product in Defendant’s
`
`possession that is covered by paragraph 9, if Defendants later intend to resume
`
`processing, manufacturing, preparing, packing, holding, or distributing food, they must
`
`first notify the United States Food and Drug Administration (“FDA”) in writing at least
`
`ninety (90) calendar days in advance of resuming operations and comply with Paragraph
`
`8 of this Decree. This notice shall identify the type(s) of food Defendants intend to
`
`receive, prepare, process, pack, hold, or distribute. Defendants shall not resume
`
`operations until FDA has inspected the Defendants’ facility(ies) and operations pursuant
`
`to Paragraph 8(B)(xiv), Defendants have paid the costs of such inspection(s) pursuant to
`
`Paragraph 12, and Defendants have received written notice from FDA, as required by
`
`Paragraph 8(B)(xv), and then shall resume operations only to the extent authorized in
`
`FDA’s written notice.
`
`8. Upon entry of this Decree, Defendants and each and all of their directors,
`
`officers, agents, representatives, employees, attorneys, successors, assigns, and any and
`
`all persons in active concert or participation with any of them (including individuals,
`
`Consent Decree of Permanent Injunction
`
` 3
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`

`

`Case 1:20-cv-03191-SAB ECF No. 3 filed 01/14/21 PageID.46 Page 4 of 17
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`directors, partnerships, corporations, subsidiaries, and affiliates) who receive notice of
`
`this Decree, 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, at or from
`
`any facility from which Defendants receive, prepare, process, manufacture, pack, hold,
`
`and/or distribute food (“Defendants’ facilities”), any article of food, unless and until the
`
`following occur:
`
`A. Defendants select an expert or experts (the “sanitation expert”) having no
`
`personal or financial ties (other than a consulting agreement) to the Defendants or the
`
`Defendants’ manufacturing operations and who, by reason of background, education,
`
`training, and experience, is qualified to develop, and ensure adequate implementation of,
`
`a written sanitation control program, covering the Defendants’ manufacturing processes,
`
`cleaning and sanitizing operations, pest control, employee health and hygiene
`
`precautions, and plant construction and maintenance (including the plant’s buildings and
`
`sanitation-related systems (plumbing, sewage disposal), equipment, and utensils
`
`contained therein), to protect against contamination of food, food-contact surfaces, and
`
`food-packaging materials with chemicals, toxins, microorganisms, and filth;
`
`i. Defendants inform FDA in writing of the name and qualifications of
`
`the sanitation expert(s) as soon as they retain such expert. The sanitation expert(s)
`
`develops a written sanitation control program for preparing, packing, holding, and
`
`distributing the Defendants’ juice products;
`
`Consent Decree of Permanent Injunction
`
` 4
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`

`

`Case 1:20-cv-03191-SAB ECF No. 3 filed 01/14/21 PageID.47 Page 5 of 17
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`ii. FDA approves, in writing, the sanitation control program developed
`
`by the sanitation expert(s);
`
`iii. Defendants make English and Spanish versions of the sanitation
`
`control program available and accessible to all their employees;
`
`iv. Defendants develop a written employee training program (in English
`
`and Spanish) that includes, at a minimum, instruction in sanitation control requirements
`
`for food-handling and manufacturing, and the Defendants document that each employee
`
`has received such training;
`
`v. Defendants assign the responsibility and authority for implementing
`
`and monitoring the sanitation control program on a continuing basis to an employee who
`
`is trained in sanitation control requirements;
`
`vi. The sanitation expert(s) inspects the Defendants’ plant, including the
`
`buildings, sanitation-related systems, equipment, utensils, articles of food, and relevant
`
`records contained therein to determine whether the Defendants have adequately
`
`established and implemented the FDA-approved sanitation control program, whether
`
`Defendants have adequately addressed the FDA investigators’ inspectional observations
`
`listed on each Form FDA-483 issued to the Defendants since 2016, and whether
`
`Defendants comply with Current Good Manufacturing Practice (“CGMP”) requirements
`
`set forth in 21 C.F.R. Part 117 subparts A, B, and F; and
`
`vii. The sanitation expert certifies in writing to FDA that Defendants:
`
`(a) have adequately established and implemented the FDA-approved sanitation control
`
`Consent Decree of Permanent Injunction
`
` 5
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`

`

`Case 1:20-cv-03191-SAB ECF No. 3 filed 01/14/21 PageID.48 Page 6 of 17
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`program; (b) have adequately addressed FDA investigators’ inspectional observations
`
`listed on each Form FDA-483 issued to the Defendants since 2016; and (c) comply with
`
`the CGMP requirements in 21 C.F.R. Part 117 subparts A, B, and F.
`
`B. Defendants retain, at Defendants’ expense, an independent person or
`
`persons (“expert”), who by reason of background, education, training, and experience, is
`
`qualified to develop and implement a Hazard Analysis Critical Control Point (“HACCP”)
`
`plan for juice. The expert shall be without personal or financial ties (other than the
`
`consulting agreement between the parties) to Defendants or their immediate families.
`
`i. Defendants shall notify the United States Food and Drug
`
`Administration (“FDA”) in writing of the identity of the expert as soon as they retain
`
`such expert;
`
`ii. The expert develops written HACCP plans for each type of juice
`
`processed by Defendants, consistent with 21 C.F.R. § 120.8(a)-(c);
`
`iii. FDA has approved, in writing, the HACCP plan developed by the
`
`expert;
`
`iv. Defendants establish and implement to FDA’s satisfaction the written
`
`HACCP plan, developed by the expert and approved in writing by FDA, that is adequate
`
`to control food safety hazards likely to occur in juice processing, as required by 21 C.F.R.
`
`§§ 120.7 and 120.8;
`
`v. Defendants perform a root cause analysis to determine sources of
`
`patulin and arsenic;
`
`Consent Decree of Permanent Injunction
`
` 6
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`

`

`Case 1:20-cv-03191-SAB ECF No. 3 filed 01/14/21 PageID.49 Page 7 of 17
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`vi. Defendants have the expert validate and certify in writing to FDA that
`
`the control measures in Defendants’ HACCP plan for apple and pear products are
`
`adequate to consistently control patulin;
`
`vii. Defendants have the expert validate and certify in writing to FDA that
`
`the control measures in Defendants’ HACCP plan for apple products are adequate to
`
`consistently control arsenic;
`
`viii. The expert develops storage and traceability procedures for all food
`
`commodities, including grape juice concentrate;
`
`ix. Defendants disclose to each customer in writing that receives any
`
`shipment as of or after the date of this Decree, all lots of juice product that has been
`
`blended into any distributed lot are within the expiration date of the final distributed lot;
`
`x.
`
`FDA has inspected Defendants’ facilities, including all records
`
`relating to the receipt, processing, manufacturing, preparation, packing, holding, and
`
`distribution of juice; and
`
`xi. FDA has notified Defendants, in writing, that the processes and
`
`controls used for the receipt, processing, manufacturing, preparation, packing, holding,
`
`and distribution of food appear to be in compliance with all of the requirements specified
`
`in Paragraph 8 of this Decree, the Act, 21 C.F.R. Part 117 subparts A, B, and F, and 21
`
`C.F.R. Part 120. And, if such notification is based upon one or more FDA inspections,
`
`Defendants have paid for such inspection(s) and other work at the rates specified in
`
`Paragraph 12.
`
`Consent Decree of Permanent Injunction
`
` 7
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`

`

`Case 1:20-cv-03191-SAB ECF No. 3 filed 01/14/21 PageID.50 Page 8 of 17
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`9. Within ten (10) days of the entry of this Decree, Defendants shall provide to
`
`FDA an inventory of all remaining juice product, which will be stored at the facility at
`
`130 US Grape Road, Sunnyside, WA 98944 until it is destroyed. Within two hundred
`
`seventy (270) days of the entry of this Decree, all juice product that is in the Defendants’
`
`possession at the time this Decree is signed by the parties shall be destroyed by the
`
`Defendants, at their own cost. Defendants shall provide FDA, every thirty (30) days from
`
`the date of entry of the Decree until the end of the two hundred seventy (270) day period,
`
`photographic evidence of Defendants’ efforts to ship product for destruction, and a
`
`destruction report, consisting of certificates of destruction from the facility the
`
`Defendants use to dispose of the product, detailed with the quantity and lot numbers of
`
`barrels destroyed. If Defendants cannot ship any barrels of juice product for destruction
`
`within a particular thirty day period due to weather conditions or unavailability of a
`
`composter or landfill, Defendants must submit a letter to FDA detailing the reason(s) that
`
`they could not ship any product for destruction during that time period.
`
`10. FDA shall be permitted, without prior notice and as and when FDA deems
`
`necessary, to make inspections of Defendants’ facilities 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
`
`Consent Decree of Permanent Injunction
`
` 8
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`

`

`Case 1:20-cv-03191-SAB ECF No. 3 filed 01/14/21 PageID.51 Page 9 of 17
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`ingredients, in-process and finished articles of food, containers, and packaging material;
`
`and to examine and copy all records related to receiving, preparing, processing,
`
`manufacturing, packing, holding, and/or distributing any and all articles of food. The
`
`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, manufacturing, packing,
`
`holding, or distribution of juice. Defendants shall maintain a copy of their HACCP plan
`
`and all records required by their HACCP plan and 21 C.F.R. Part 120 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 the HACCP plan and by regulation
`
`shall be retained for at least three (3) years after the date they are prepared and shall be
`
`presented immediately to FDA investigators upon request.
`
`12. Defendants shall pay all costs of FDA’s supervision, inspections,
`
`investigations, analyses, examinations, and reviews that FDA deems necessary to
`
`evaluate Defendants’ 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: $101.00 per hour and fraction thereof per representative for inspection work;
`
`$121.06 per hour or fraction thereof per representative for analytical or review work;
`
`$.575 per mile for travel by automobile; government rate or the equivalent for travel by
`
`Consent Decree of Permanent Injunction
`
` 9
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`

`

`Case 1:20-cv-03191-SAB ECF No. 3 filed 01/14/21 PageID.52 Page 10 of 17
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`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.
`
`13. Defendants and each and all of their directors, officers, agents,
`
`representatives, employees, attorneys, successors, assigns, and any and all persons in
`
`active concert or participation with any of them (including individuals, directors,
`
`partnerships, corporations, subsidiaries, and affiliates) who have received notice of this
`
`Decree, are permanently restrained and enjoined pursuant to 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. § 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) or 21 U.S.C. § 342(a)(3);
`
`b. violates 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) or 21 U.S.C. § 342(a)(3), while
`
`such articles are held for sale after shipment of one or more components in interstate
`
`commerce; and/or
`
`c.
`
`results in the failure to implement and continuously maintain the
`
`requirements of this Decree.
`
`14.
`
`If, at any time after entry of this Decree, FDA determines, based on the results
`
`Consent Decree of Permanent Injunction
`
` 10
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`

`

`Case 1:20-cv-03191-SAB ECF No. 3 filed 01/14/21 PageID.53 Page 11 of 17
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`of an inspection, sample analysis, a report or data submitted by Defendants or the
`
`expert(s), or any other information, that Defendants have failed to comply with any
`
`provision of this Decree, the Act, or its implementing regulations, or that additional
`
`corrective actions are necessary to achieve compliance with this Decree, the Act, or its
`
`implementing regulations, FDA may, as and when it deems necessary, notify Defendants
`
`in writing of the noncompliance and order Defendants to take appropriate action
`
`immediately, including, but not limited to, one or more of the following:
`
`a. Cease receiving, processing, manufacturing, preparing, packing, holding,
`
`and/or distributing any articles of food, until Defendants receive written notification from
`
`FDA that Defendants appear to be in compliance with the Decree, the Act, and its
`
`implementing regulations, and that Defendants may resume operations;
`
`b. Recall all articles of food that have been distributed and/or are under the
`
`custody and control of Defendants’ agents, distributors, customers, or consumers;
`
`c. Submit samples of raw ingredients, in-process or finished articles of food,
`
`containers, and/or packaging materials to a qualified laboratory to determine whether
`
`they are contaminated with chemicals, toxins, microorganisms, and/or filth; and/or
`
`d. Take any other corrective actions as FDA deems necessary to protect the
`
`public health or bring Defendants into compliance with this Decree, the Act, and its
`
`implementing regulations, including, but not limited to, requiring that Defendants re-
`
`implement or re-institute any of the requirements of this Decree.
`
`15. The provisions of Paragraph 14 shall be apart from, and in addition to, all
`
`Consent Decree of Permanent Injunction
`
` 11
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`

`

`Case 1:20-cv-03191-SAB ECF No. 3 filed 01/14/21 PageID.54 Page 12 of 17
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`other remedies available to FDA. Defendants shall pay all costs of recalls and other
`
`corrective actions, including the costs of FDA’s supervision, inspections, investigations,
`
`analyses, examinations, and reviews to implement and monitor recalls and other
`
`corrective actions, at the rates specified in Paragraph 12 of this Decree.
`
`16. Upon receipt of an FDA order described in Paragraph 14, Defendants shall
`
`immediately and fully comply with the terms of the order, and shall continue to comply
`
`with such terms, until Defendants receive written notification from FDA that Defendants
`
`appear to be in compliance with this Decree, the Act, and its implementing regulations.
`
`After a cessation of operations , and while determining whether Defendants are in
`
`compliance with this Decree, the Act, and its implementing regulations, FDA may
`
`require Defendants to re-institute or re(cid:173)implement any of the requirements of this Decree.
`
`17.
`
`If any Defendant fails to comply with the provisions of this Decree, the Act,
`
`and/or its implementing regulations, then Defendants shall pay to the United States of
`
`America liquidated damages in the sum of two thousand dollars ($2000.00) for each
`
`violation of this Decree, the Act, and/or its implement regulations; an additional sum of
`
`two hundred fifty dollars ($250.00) for each day that the Defendants fail to comply with
`
`this Decree, the Act, and/or its implementing regulations; and an additional sum equal to
`
`twice the retail value of each shipment of adulterated food. Defendants understand and
`
`agree that the liquidated damages specified in this Paragraph are not punitive in nature
`
`and their imposition does not in any way limit the ability of the United States to seek, and
`
`the Court to impose, additional criminal or civil penalties based on conduct that may also
`
`Consent Decree of Permanent Injunction
`
` 12
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`

`

`Case 1:20-cv-03191-SAB ECF No. 3 filed 01/14/21 PageID.55 Page 13 of 17
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`be the basis for payment of the liquidated damages.
`
`18.
`
`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.
`
`19. 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.
`
`20. 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 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
`
`Consent Decree of Permanent Injunction
`
` 13
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`

`

`Case 1:20-cv-03191-SAB ECF No. 3 filed 01/14/21 PageID.56 Page 14 of 17
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`Defendants’ facilities, 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.
`
` Within twenty (20) calendar days after entry of this Decree, Defendants shall
`
`provide FDA with 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.
`
`21.
`
`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 processing, manufacturing, preparing, packing, holding, and/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 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
`
`Consent Decree of Permanent Injunction
`
` 14
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`

`

`Case 1:20-cv-03191-SAB ECF No. 3 filed 01/14/21 PageID.57 Page 15 of 17
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`Defendants’ compliance with this Paragraph, Defendants shall provide such information
`
`or documentation to FDA.
`
`22. 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.
`
`23. Defendants shall address all communications required under this Decree to
`
`the HAFW6 /Seattle District Office 22215 26th Avenue SE, Suite 210, Bothell,
`
`Washington, with a copy to orahafwest6firmresponses@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.
`
`24. This Court retains jurisdiction of this action for the purpose of enforcing or
`
`modifying this Decree and for the purpose of granting such additional relief as may be
`
`necessary or appropriate.
`
`SO ORDERED this day of , 2021.
`Consent Decree of Permanent Injunction
` 15
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`14th
`
`January
`
`

`

`Case 1:20-cv-03191-SAB ECF No. 3 filed 01/14/21 PageID.58 Page 16 of 17
`
` United States District Judge
`
`We hereby consent to the entry of the forgoing Decree:
`
`LOCAL COUNSEL:
`
`FOR PLAINTIFF:
`
`WILLIAM D. HYSLOP
`United States Attorney
`
`TIM M. DURKIN
`Chief, Civil Division
`Assistant United States Attorney
`Post Office Box 1494
`Spokane, WA 99210
`Telephone: (509) 835-6324
`
`JEFFREY B. CLARK
`Acting Assistant Attorney General
`Civil Division
`
`
` DAVID J. FEITH
`Deputy Assistant Attorney General
`
`GUSTAV W. EYLER
`Director
`
` s/Kendrack D. Lewis
`KENDRACK D. LEWIS
`Trial Attorney
`Consumer Protection Branch, Civil Division
`U.S. Department of Justice
`P.O. Box 386
`Washington, D.C. 20044
`
`Of Counsel:
`
`ROBERT P. CHARROW
`General Counsel
`U.S. Dep’t of Health and Human Services
`
`STACY CLINE AMIN
`Chief Counsel
`Food and Drug Administration
`Deputy General Counsel
`U.S. Dep’t of Health and Human Services
`
`ANNAMARIE KEMPIC
`Deputy Chief Counsel, Litigation
`
`TARA BOLAND
`Senior Counsel
`Food and Drug Administration
`10903 New Hampshire Avenue
`Silver Spring, MD 20993-0002
`
`Consent Decree of Permanent Injunction
`
` 16
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`

`

`Case 1:20-cv-03191-SAB ECF No. 3 filed 01/14/21 PageID.59 Page 17 of 17
`
`FOR DEFENDANTS:
`
`Consent Decree of Permanent Injunction
`
` 17
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`