UNITED STATES DISTRICT COURT 

EASTERN DISTRICT OF MICHIGAN 

UNITED STATES OF AMERICA, 

 Plaintiff, 

v. 

SCOTTY’S INCORPORATED, 

a corporation, d/b/a 

BRUCE ENTERPRISES and 

BRUCE’S FRESH PRODUCTS, 

 and 

SANDRA J. JACKSON 

an individual, 

 Defendants 

Case 2:14-cv-14450-RHC-RSW 

 

 ORDER OF PERMANENT INJUNCTION 

 Plaintiff, the United States of America, by its undersigned attorneys, having filed a 

Complaint for Permanent Injunctive Relief and Motion for Summary Judgment against Scotty’s 

Incorporated (“Scotty’s Inc.” or “the firm”) and Sandra J. Jackson (collectively, “Defendants”), 

and Defendants having appeared and it having been shown that Defendants are violating, and 

unless restrained by order of this Court, will continue to violate the Federal Food, Drug, and 

Cosmetic Act (the “Act”), 21 U.S.C. §§ 301–399f; 

IT IS HEREBY ORDERED that: 

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

action. 

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2. The Complaint for Permanent Injunction states a cause of action against 

Defendants under the Act. 

3. Defendants violate the Act, 21 U.S.C. § 331(a), by introducing or delivering for 

introduction, or causing to be introduced or delivered for introduction, into interstate commerce 

articles of food, namely, ready-to-eat (“RTE”) sandwiches, that are adulterated within the 

meaning of 21 U.S.C. § 342(a)(4). 

4. Defendants violate the Act, 21 U.S.C. § 331(k), by doing an act that causes the 

adulteration, within the meaning of 21 U.S.C. § 342(a)(4), of articles of food, namely, RTE 

sandwiches, while such articles are held for sale after shipment of one or more components in 

interstate commerce. 

5. Defendants and each and all of their officers, agents, employees, representatives, 

successors, assigns, attorneys, and any and all persons in active concert or participation with any 

of them (including individuals, directors, corporations, subsidiaries, affiliates, and partnerships) 

are hereby permanently restrained and enjoined, under the provisions of 21 U.S.C. § 332(a) and 

the equitable authority of this Court, from directly or indirectly receiving, preparing, processing, 

packing, holding, and distributing RTE sandwiches, at or from their facility located at 3426 

Junction Street, Detroit, Michigan, and any other locations at or from which Defendants now or 

in the future, receive, prepare, process, pack, hold, or distribute any RTE sandwiches, unless and 

until: 

A. Defendants retain a person (or persons) (the “expert”) who is without any 

personal or financial ties (other than the retention agreement) to Defendants, and who, by reason 

of background, education, training, and experience, is qualified to: 

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1. Ensure that Defendants comply with the Act and current good 

manufacturing practice requirements for food (“CGMP”), 21 C.F.R. Part 110; 

2. Develop, and ensure proper implementation of, a written sanitation 

control program encompassing all of Defendants’ operations to ensure that Defendants comply 

with the Act and CGMP requirements, 21 C.F.R. Part 110; 

3. Ensure that Defendants comply with the seafood hazard analysis 

and critical control point regulations (“HACCP”), 21 C.F.R. Part 123, when processing seafood 

products, including conducting hazard analyses, developing a written HACCP plan(s) and 

recordkeeping system(s), validating processes, and verifying the proper implementation of the 

HACCP control program; 

4. Develop and conduct employee training programs on sanitation 

controls, CGMP, and seafood HACCP regulations; and 

5. Inspect Defendants’ facility and establish procedures to ensure that 

the methods, facilities, and controls are continuously administrated in conformity with this 

Order, the Act, and all applicable regulations. Defendants shall notify the United States Food 

and Drug Administration (“FDA”) in writing of the identity and qualifications of the expert 

within five (5) business days after retaining such expert; 

B. Defendants have submitted to FDA the following, created by or with the 

expert identified in paragraph 5.A: 

1. A written sanitation control program encompassing all of 

Defendants’ operations, to ensure that Defendants comply with the Act and 21 C.F.R. Part 110; 

2. Written HACCP plans for each and every type of seafood received, 

prepared, processed, packed, held, and/or distributed by Defendants for which food safety 

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hazards are identified, including critical control points and critical limits, as required by 21 

C.F.R. § 123.6; 

3. Written corrective action plans, as part of the HACCP plan(s), to 

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

4. Employee training programs, translated into each employee’s 

native language, on all foodborne hazards, including the sanitation control program, the CGMP 

requirements, and seafood HACCP regulations; and 

5. A plan to destroy all finished and in-process RTE sandwiches, 

including RTE sandwich ingredients, in Defendants’ custody, control, or possession at the time 

this Order is entered; 

C. FDA has approved, in writing, the written sanitation control program, 

HACCP plan(s), employee training programs, and destruction plan developed by the expert, as 

specified in paragraph 5.B; 

D. Defendants’ employees successfully complete the employee training 

program developed by the expert and approved in writing by FDA pursuant to paragraph 5.C, 

and Defendants submit documentation to FDA that each employee has received such training; 

E. Defendants destroy, at their expense, and under FDA supervision, all 

finished and in-process RTE sandwiches, including RTE sandwich ingredients, that are in 

Defendants’ custody, possession, or control at the time this Order is entered. Such destruction 

shall occur within twenty (20) business days after entry of this Order and shall be in accordance 

with the destruction plan developed by the expert and approved by FDA in writing pursuant to 

paragraph 5.C; 

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F. Defendants, at their expense, after destroying all finished and in-process 

RTE sandwiches, including RTE sandwich ingredients, that are in Defendants’ custody, 

possession, or control at the time this Order is entered pursuant to paragraph 5.E, clean and 

sanitize their facility and equipment therein and make improvements, rendering the facility and 

equipment suitable for receiving, preparing, processing, packing, holding, and distributing RTE 

sandwiches, and Defendants ensure that the facility and equipment therein will be continuously 

maintained in a sanitary condition; 

G. Defendants report to FDA, in writing, the actions they have taken to bring 

their operations into compliance with this Order, the Act, and all applicable regulations, 

including specific measures they have taken to address each of the deficiencies documented by 

FDA since 2006; 

H. The expert conducts a comprehensive inspection of Defendants’ facility 

and the methods and controls used to receive, prepare, process, pack, hold, and distribute RTE 

sandwiches to determine whether Defendants’ processing facility is sanitary and Defendants are 

fully prepared to operate in compliance with this Order, the Act, and all applicable regulations. 

The expert shall verify that Defendants have corrected all of the deficiencies documented by 

FDA. The expert shall submit all findings, in writing, concurrently to Defendants and FDA, 

within ten (10) business days after completion of the inspection; 

I. FDA, as it deems necessary to evaluate Defendants’ compliance with the 

terms of this Order, the Act, and all applicable regulations, conducts inspections of Defendants’ 

facility, including the buildings, sanitation-related systems, equipment, utensils, all RTE 

sandwiches, and relevant records contained therein; 

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J. Defendants pay all costs of supervision, inspections, investigations, 

analyses, examinations, and reviews for FDA’s oversight with respect to paragraphs 5.A through 

5.I, at the rates set forth in paragraph 9 below; and 

K. FDA notifies Defendants in writing that they appear to be in compliance 

with the requirements set forth in paragraphs 5.A through 5.J of this Order, the Act, and all 

applicable regulations. 

6. Immediately upon resuming operations after completing the requirements set 

forth in paragraph 5, Defendants shall, in consultation with the expert, continuously implement 

the sanitation program, HACCP plan(s), and training program developed by the expert and 

approved in writing by FDA pursuant to paragraph 5.C. Within twenty (20) business days after 

Defendants’ resumption of operations, the expert shall conduct a comprehensive inspection of 

Defendants’ facility and the methods and controls used to receive, prepare, process, pack, hold, 

and distribute RTE sandwiches to determine whether Defendants are operating in compliance 

with this Order, the Act, and all applicable regulations. The expert shall submit a report 

documenting all findings concurrently to Defendants and FDA within ten (10) business days 

after completion of this inspection. Thereafter, the expert shall conduct inspections every three 

(3) months for three (3) years, and then annually for the next two (2) years. The expert shall 

submit a report documenting all findings concurrently to Defendants and FDA within ten (10) 

business days after completion of each inspection. 

7. Defendants and each and all of their agents, representatives, employees, attorneys, 

successors, assigns, and any and all persons in active concert or participation with any of them 

(including individuals, directors, corporations, subsidiaries, affiliates, and partnerships) who 

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receive actual notice of this Order, 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: 

A. violates the Act, 21 U.S.C. § 331(a), by introducing or delivering for 

introduction, or causing to be introduced or delivered for introduction, into interstate commerce 

articles of food that are adulterated within the meaning of 21 U.S.C. § 342(a)(4); 

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) while such articles are held for sale after 

shipment of one or more components in interstate commerce; or 

C. results in the failure to implement and continuously maintain the 

requirements of this Order. 

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

necessary, to make inspections of Defendants’ facility and any other locations at which 

Defendants receive, prepare, process, pack, hold, or distribute RTE sandwiches, and, without 

prior notice, to take any other measures necessary to monitor and ensure continuing compliance 

with the terms of this Order, the Act, and all applicable regulations. During the inspections, 

FDA shall be permitted to have immediate access to buildings, equipment, raw ingredients, inprocess and finished RTE sandwiches, containers, and packaging material therein; to take 

photographs and make video recordings; to take samples of Defendants’ raw ingredients, inprocess, and finished RTE sandwiches, containers, and packaging material; and to examine and 

copy all records related to receiving, preparing, processing, packing, holding, and distributing 

any and all RTE sandwiches. The inspections shall be permitted upon presentation of a copy of 

this Order and appropriate credentials. The inspection authority granted by this Order is apart 

from, and in addition to, the authority to make inspections under the Act, 21 U.S.C. § 374. 

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9. Defendants shall reimburse FDA for the costs of all FDA inspections, 

investigations, supervision, analyses, examinations, and reviews that FDA deems necessary to 

evaluate Defendants’ compliance with any part of this Order. The costs of such activities shall 

be borne by Defendants at the prevailing rates in effect at the time the costs are incurred. As of 

the date that this Order is signed by the parties, these rates are: $89.35 per hour or fraction 

thereof per representative for inspection or investigative work; $107.09 per hour or fraction 

thereof per representative for analytical or review work; $0.575 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 or the equivalent for the areas in which the inspections are performed 

per-day, per-representative for subsistence expenses, where necessary. In the event that the 

standard rates applicable to FDA supervision of court-ordered compliance are modified, these 

rates shall be increased or decreased without further order of the Court. 

10. Defendants shall promptly provide any information or records to FDA regarding 

the receiving, preparing, processing, packing, holding, and distribution of RTE sandwiches upon 

request. Defendants shall maintain copies of their HACCP plan(s), and all records required by 

their HACCP plan(s) and 21 C.F.R. Part 123, at their 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(s), by regulation, and/or this Order, 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. 

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

an inspection, sample analysis, or other information, that Defendants have failed to comply with 

any provision of this Order, have violated the Act or its implementing regulations, or that 

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additional corrective actions are necessary to achieve compliance with this Order, the Act, or its 

implementing regulations, FDA may, as and when it deems necessary, notify Defendants in 

writing and order Defendants to take appropriate action, including, but not limited to, ordering 

Defendants to immediately take one or more of the following actions: 

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

RTE sandwiches; 

B. Recall all RTE sandwiches that have been distributed or are under the 

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

C. Institute or re-implement any of the requirements set forth in this Order; 

and/or 

D. Take any other corrective actions as FDA deems necessary to bring 

Defendants into compliance with this Order, the Act, and all applicable regulations. 

The provisions of this paragraph shall be separate and apart from, and in addition to, all 

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, review, travel, and subsistence expenses to implement and monitor recalls and 

other corrective actions, at the rates specified in paragraph 9 of this Order. 

12. Any cessation of operations as described in paragraph 11(A) shall be 

implemented immediately upon notice from FDA and shall continue until Defendants receive 

written notification from FDA that Defendants appear to be in compliance with the Order, the 

Act, and all applicable regulations. 

13. Within ten (10) business days after entry of this Order, Defendants shall provide a 

copy of this Order, by personal service or certified mail (restricted delivery, return receipt 

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requested), to each and all of their officers, agents, employees, representatives, successors, 

assigns, attorneys, and any and all persons in active concert or participation with any of them 

(including individuals, directors, corporations, subsidiaries, affiliates, and partnerships). 

Defendants shall provide to FDA within twenty (20) business days after the date of entry of this 

Order, an affidavit of compliance with this paragraph stating the fact and manner of compliance 

and identifying the names and positions of all persons so notified. 

14. Defendants shall prominently post a copy of this Order in an employee common 

area at Defendants’ facility within ten (10) business days after entry of this Order and shall 

ensure that the Order remains posted for a period of at least six (6) months. 

15. Defendants shall, within ten (10) business days after entry of this Order, hold a 

general meeting or series of smaller meetings for employees of Defendants’ facility, at which 

they shall describe the terms and obligations of this Order. 

16. In the event that any Defendant becomes associated with any additional officers, 

agents, employees, representatives, successors, assigns, attorneys, or any additional persons in 

active concert or participation with any of them (including individuals, directors, corporations, 

subsidiaries, affiliates, and partnerships) at any time after entry of this Order, Defendants shall 

immediately provide a copy of this Order, by personal service or certified mail (restricted 

delivery, return receipt requested), to such persons. Within ten (10) business days after each 

instance that any Defendant becomes associated with any such additional 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 Order pursuant to this paragraph. Within ten (10) business days after receiving a 

request from FDA for any information or documentation that FDA deems necessary to evaluate 

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Defendants’ compliance with this paragraph, Defendants shall provide such information or 

documentation to FDA. 

17. Defendants shall notify FDA in writing at least fifteen (15) business days before 

any change in ownership, character, or name of its business, such as dissolution, assignment, or 

sale resulting in the emergence of a successor corporation, the creation or dissolution of 

subsidiaries, franchisees, affiliates, or “doing business as” entities, or any other change in the 

corporate structure of Defendant Scotty’s Incorporated, or in the sale or assignment of any 

business assets, such as buildings, equipment, or inventory, that may affect compliance with this 

Order. Defendants shall provide a copy of this Order to any potential successor or assignee at 

least fifteen (15) business days before any sale or assignment. Defendants shall furnish FDA 

with an affidavit of compliance with this paragraph no later than ten (10) business days prior to 

such assignment or change in ownership. 

18. If any Defendant fails to comply with the provisions of the Act, its implementing 

regulations, and/or this Order, then Defendants shall pay to the United States of America 

liquidated damages in the sum of one thousand dollars ($1,000.00) for each day that Defendants 

fail to comply with this Order; an additional sum of five hundred dollars ($500.00) in liquidated 

damages per day for each violation of this Order, the Act, and/or all applicable regulations; and 

an additional sum equal to twice the retail value of each shipment of adulterated RTE 

sandwiches. 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 be the basis for payment of the liquidated damages. 

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19. If any Defendant violates this Order and is found in contempt thereof, Defendants 

shall, in addition to other remedies, reimburse Plaintiff for its attorneys’ fees, travel expenses 

incurred by attorneys and witnesses, expert witness fees, administrative and court costs, 

investigation and analytical expenses incurred in bringing the contempt action, and any other 

costs or fees related to the contempt proceedings. 

20. All decisions specified in this Order shall be vested in the discretion of FDA. 

FDA’s decisions shall be final and, to the extent that these decisions are subject to review, shall 

be reviewed by the Court under the arbitrary and capricious standard set forth in 5 U.S.C. 

§ 706(2)(A). Review by the Court of any FDA decision rendered pursuant to this Order 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. 

21. Defendants shall address all communications with FDA required under this Order 

to Director, Detroit District Office, Food and Drug Administration, 300 River Place Drive, Suite 

5900, Detroit, Michigan 48207, and shall reference this civil action by case name and civil action 

number in such communications. 

22. This Court shall retain jurisdiction of this action and the parties hereto for the 

purpose of enforcing or modifying this Order and for the purpose of granting such additional 

relief as may be necessary or appropriate. 

SO ORDERED: 

 S/Robert H. Cleland 

 ROBERT H. CLELAND 

 UNITED STATES DISTRICT JUDGE 

Dated: May 12, 2016 

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I hereby certify that a copy of the foregoing document was mailed to counsel of record 

and/or pro se parties on this date, May 12, 2016, by electronic and/or ordinary mail. 

 S/Lisa Wagner 

 Case Manager and Deputy Clerk 

 (313) 234-5522 

 

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