throbber
Case 1:22-cv-00441-HYJ-SJB ECF No. 8, PageID.62 Filed 05/16/22 Page 1 of 33
`
`UNITED STATES DISTRICT COURT
`WESTERN DISTRICT OF MICHIGAN
`SOUTHERN DIVISION
`
`UNITED STATES OF AMERICA,
`
`Plaintiff,
`
`v.
`
`ABBOTT LABORATORIES, a corporation
`doing business as ABBOTT NUTRITION, and
`KEENAN S. GALE, TJ HATHAWAY, and
`LORI J. RANDALL, individuals,
`
`Defendants.
`_________________________________________/
`
`Case No. 1:22-cv-441
`
`Hon. Hala Y. Jarbou
`
`CONSENT DECREE OF PERMANENT INJUNCTION
`
`Plaintiff, the United States of America, by its undersigned counsel and on behalf of the
`
`United States Food and Drug Administration (“FDA”), having filed a Complaint for Permanent
`
`Injunction (“Complaint”) against Abbott Laboratories, a corporation doing business as Abbott
`
`Nutrition, and Keenan S. Gale, TJ Hathaway, and Lori J. Randall, 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 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:
`
`1.
`
`This Court has jurisdiction over the subject matter and over all parties to this
`
`action under 28 U.S.C. §§ 1331 and 1345, 21 U.S.C. § 332, and its inherent equitable authority.
`
`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. (“Act”).
`
`3.
`
`The Complaint alleges that Defendants violate 21 U.S.C. § 331(a) by introducing
`
`or causing to be introduced, or delivering or causing to be delivered for introduction, into
`
`

`

`Case 1:22-cv-00441-HYJ-SJB ECF No. 8, PageID.63 Filed 05/16/22 Page 2 of 33
`
`interstate commerce articles of food that are adulterated within the meaning of 21 U.S.C.
`
`§ 342(a)(4).
`
`4.
`
`The Complaint alleges that Defendants violate 21 U.S.C. § 331(a) by introducing
`
`or causing to be introduced, or delivering or causing to be delivered for introduction, into
`
`interstate commerce articles of food, namely infant formula as defined in 21 U.S.C. § 321(z), that
`
`are adulterated within the meaning of 21 U.S.C. § 350a(a)(3), 21 U.S.C. § 350a(b)(2), and 21
`
`C.F.R. Part 106.
`
`5.
`
`The Complaint alleges that Defendants violate 21 U.S.C. § 331(k) by causing
`
`articles of food that are held for sale after shipment of one or more of their components in
`
`interstate commerce to become adulterated within the meaning of 21 U.S.C. § 342(a)(4).
`
`6.
`
`The Complaint alleges that Defendants violate 21 U.S.C. § 331(k) by causing
`
`articles of food, namely infant formula as defined in 21 U.S.C. § 321(z), that are held for sale
`
`after shipment of one or more of their components in interstate commerce to become adulterated
`
`within the meaning of 21 U.S.C. § 350a(a)(3).
`
`7.
`
`For purposes of this Decree, the following definitions shall apply:
`
`A.
`
`“Associated Persons” shall refer collectively to each and all of
`
`Defendants’ officers, agents, employees, attorneys, successors, and assigns, and any and all
`
`persons in active concert or participation with any of them (including individuals, partnerships,
`
`corporations, subsidiaries, and “doing business as” entities) who are involved with the
`
`manufacture, processing, preparing, packing, labeling, holding, or distribution of articles of food
`
`covered by paragraph 7(F) or paragraph 7(G) at or from the Sturgis Facility;
`
`B.
`
`“CGMP Regulations for Human Food” shall refer to the current good
`
`manufacturing practice requirements in Subpart B of 21 C.F.R. Part 117 (Current Good
`
`2
`
`

`

`Case 1:22-cv-00441-HYJ-SJB ECF No. 8, PageID.64 Filed 05/16/22 Page 3 of 33
`
`Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human
`
`Food);
`
`C.
`
`D.
`
`“Days” shall refer to business days;
`
`“Infant Formula CGMP Regulations” shall refer to the current good
`
`manufacturing practice requirements in Subpart B of 21 C.F.R. Part 106 (Infant Formula
`
`Requirements Pertaining to Current Good Manufacturing Practice, Quality Control Procedures,
`
`Quality Factors, Records and Reports, and Notifications);
`
`E.
`
`“Inventory Products” shall refer only to the non-recalled powdered
`
`finished products manufactured at the Sturgis Facility and in Defendants’ possession, custody, or
`
`control as of March 18, 2022, the close of FDA’s inspection at Defendants’ facilities located at
`
`901 North Centerville Road, Sturgis, Michigan 49091;
`
`F.
`
`“Other Operations” shall refer to Defendants’ manufacture, processing,
`
`preparing, packing, labeling, holding, and/or distribution at or from the Sturgis Facility of any
`
`infant formula, as that term is defined in 21 U.S.C. § 321(z), in powdered form, except for
`
`Inventory Products defined in paragraph 7(E) and products subject to Specialty Operations
`
`described in paragraph 7(G);
`
`G.
`
`“Specialty Operations” shall refer to Defendants’ manufacture, processing,
`
`preparing, packing, labeling, holding, and/or distribution at or from the Sturgis Facility of any
`
`article of food that is:
`
`or
`
`(1) Any powdered infant formula covered by 21 U.S.C. § 350a(h)(1);
`
`3
`
`

`

`Case 1:22-cv-00441-HYJ-SJB ECF No. 8, PageID.65 Filed 05/16/22 Page 4 of 33
`
`(2) Any powdered product for non-infants (older than 12 months of
`
`age) that serves similar nutritional purposes as any formulation of powdered infant formula
`
`covered by 21 U.S.C. § 350a(h)(1); and
`
`H.
`
`“Sturgis Facility” shall refer to the facilities located at 901 North
`
`Centerville Road, Sturgis, Michigan 49091.
`
`Specialty Operations
`
`8.
`
`Subject to paragraph 11(A), upon entry of this Decree, Defendants and each and
`
`all of their Associated Persons who have received actual 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 conducting Specialty Operations, unless all the following conditions are met:
`
`A.
`
`Defendants, at their expense, shall retain or continue retention of an
`
`independent person or persons (“Expert”) who is without any personal or financial ties (other
`
`than a retention agreement or agreements to satisfy the requirements of this Decree and/or to
`
`perform other consulting or testing work for Abbott Nutrition) to Defendants or their families,
`
`and who, by reason of training, education, and experience, is qualified to:
`
`(1) Evaluate the facilities, methods, processes, and controls at the
`
`Sturgis Facility to ensure that Defendants’ products are manufactured, processed, prepared,
`
`packed, labeled, held, and distributed in compliance with this Decree, the Act, the CGMP
`
`Regulations for Human Food, and the Infant Formula CGMP Regulations; and
`
`(2)
`
`Inspect the Sturgis Facility to determine whether Defendants’
`
`facilities, methods, processes, and controls are continuously operated and administered in
`
`conformity with this Decree, the Act, and its implementing regulations;
`
`4
`
`

`

`Case 1:22-cv-00441-HYJ-SJB ECF No. 8, PageID.66 Filed 05/16/22 Page 5 of 33
`
`B.
`
`Defendants shall notify FDA in writing of the identity and qualifications
`
`of the Expert within two days after retaining the Expert, and, in coordination with the Expert,
`
`Defendants shall:
`
`(1)
`
`Verify the dry-out procedures (including time and temperature
`
`controls) for production equipment and processing environments, and validate the test method
`
`for moisture verification used to assess dryness after the dry-out procedures for production
`
`equipment and processing environments. Where applicable, Defendants may rely on completed
`
`action described in Defendants’ response(s) to the FDA Form-483 issued on March 18, 2022
`
`(“Form-483 Response”);
`
`(2)
`
`Conduct pre-production cleaning, sanitizing, and dry-out of
`
`production equipment and processing environments (using the verified dry-out procedures and
`
`the validated test method), followed by environmental testing for pathogens in the processing
`
`environment. Where applicable, Defendants may rely on completed actions already conducted in
`
`coordination with the Expert or as described in Defendants’ Form-483 Response; and
`
`(3)
`
`Prior to initiating production pursuant to paragraph 8, provide FDA
`
`with the Expert’s report documenting completion of the verification and validation activities and
`
`pre-production review set out in paragraph 8(B);
`
`C.
`
`If Defendants choose to restrict Specialty Operations to specified
`
`equipment and processing environments, then Defendants shall ensure that any cleaning,
`
`sanitizing, dry-out, and/or environmental testing during the pendency of Specialty Operations of
`
`equipment and processing environments that are not part of Specialty Operations is
`
`accomplished in a manner that protects against contamination of the specified equipment and
`
`processing environments (and utensils therein) that are part of Specialty Operations;
`
`5
`
`

`

`Case 1:22-cv-00441-HYJ-SJB ECF No. 8, PageID.67 Filed 05/16/22 Page 6 of 33
`
`D.
`
`Defendants shall, as and when feasible, prioritize production in a manner
`
`that minimizes the risk of market disruption;
`
`E.
`
`Prior to distribution of each product lot produced during Specialty
`
`Operations, Defendants shall ensure that a qualified individual in Defendants’ quality unit
`
`reviews the batch record, the test results for in-process and finished product, and the
`
`environmental monitoring results that pertain to the product lot, and certifies in writing to FDA
`
`that such lot meets all specifications;
`
`F.
`
`Defendants shall ensure that environmental monitoring during Specialty
`
`Operations consists of routine sampling and, when appropriate, investigative sampling, and that a
`
`qualified individual in Defendants’ quality unit conducts trending analyses of environmental
`
`monitoring results from both routine and investigative sampling;
`
`G.
`
`Defendants shall collect in-process and finished product samples during
`
`Specialty Operations and shall analyze the powdered infant formula samples for Cronobacter
`
`spp. and Salmonella spp., in the manner specified in 21 C.F.R. § 106.55, and shall analyze the
`
`powdered non-infant product samples for Salmonella spp. If any test of in-process or finished
`
`product detects the presence of Cronobacter spp. and/or Salmonella spp., Defendants shall:
`
`(1) Cease production at the earliest time practicable and, in any event,
`
`no later than the completion of any batch then in progress, dispose of the affected in-process
`
`and/or finished product batch, conduct a thorough contamination-source determination (i.e., root-
`
`cause analysis), and adequately remediate the processing equipment and environment.
`
`Defendants shall maintain records of all the steps taken pursuant to this paragraph and shall
`
`make the records available to FDA immediately upon request. After a cessation of production
`
`pursuant to this paragraph, Defendants shall not resume production unless and until they receive
`
`6
`
`

`

`Case 1:22-cv-00441-HYJ-SJB ECF No. 8, PageID.68 Filed 05/16/22 Page 7 of 33
`
`written notice from FDA that Defendants may resume production. Within fifteen days after
`
`receipt of Defendants’ written request to resume production, unless FDA determines that, based
`
`on the complexity of the issues, a longer time frame is necessary, in which case FDA can give
`
`Defendants notice that FDA needs an additional fifteen days to complete its review, FDA will
`
`review Defendants’ request to resume production and provide written notification to Defendants
`
`either permitting resumption or explaining the basis for FDA’s decision not to permit resumption
`
`of production, including the concerns with Defendants’ submission. After addressing all
`
`concerns described in FDA’s written notification of a decision not to permit resumption,
`
`Defendants may submit a new request to resume production, and the process described in
`
`paragraph 8(G)(1) shall be repeated until Defendants receive written notification from FDA that
`
`they may resume production. In no circumstance shall FDA’s silence be construed as a
`
`substitute for written notification;
`
`(2)
`
`Forward the test results detecting the presence of Cronobacter spp.
`
`and/or Salmonella spp. in in-process and/or finished product to FDA within twenty-four hours
`
`after receipt by Defendants (along with a written statement confirming that Defendants have
`
`ceased production in accordance with paragraph 8(G)(1)), speciate each Cronobacter spp. isolate
`
`to determine whether it is Cronobacter sakazakii, and forward each Cronobacter sakazakii-
`
`positive test result to FDA within twenty-four hours of receipt by Defendants; and
`
`(3) Retain each Cronobacter sakazakii and Salmonella spp. isolate
`
`under appropriate storage conditions for three years from the date of the test result detecting the
`
`presence of Cronobacter sakazakii and/or Salmonella spp. in that isolate, and each isolate is to
`
`be provided to FDA within five days of receipt of a written request;
`
`7
`
`

`

`Case 1:22-cv-00441-HYJ-SJB ECF No. 8, PageID.69 Filed 05/16/22 Page 8 of 33
`
`H.
`
`Defendants shall maintain a record of all sales and distribution of
`
`products, including shipping documents and the following information for the product
`
`distributed: the product name; the product size and configuration if variations exist; the batch,
`
`lot, and manufacturing codes; and the names of customers to whom the product is shipped, along
`
`with quantities shipped to each such customer. Defendants shall make the records described in
`
`this paragraph available to FDA immediately upon request; and
`
`I.
`
`Defendants shall, in accordance with the procedures in paragraph 10,
`
`destroy all Inventory Products defined in paragraph 7(E) that have not been distributed within
`
`fifteen days after Defendants initiate production under Specialty Operations. The parties may
`
`mutually agree in writing to modify this fifteen-day time frame, which modification may be
`
`granted without seeking leave of Court. To the extent that Defendants are under a separate legal
`
`obligation to preserve all or a portion of the Inventory Products, Defendants shall be permitted to
`
`segregate and retain such Inventory Products for the duration of such preservation obligation.
`
`Other Operations
`
`9.
`
`Upon entry of this Decree, Defendants and each and all of their Associated
`
`Persons who have received actual 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 conducting
`
`Other Operations, unless all the following conditions are met:
`
`A.
`
`Defendants shall have continuously complied with paragraph 8 since entry
`
`of this Decree;
`
`B.
`
`Defendants shall ensure that the Sturgis Facility and equipment therein:
`
`(1) are cleaned and sanitized to render them suitable for manufacturing, processing, preparing,
`
`packing, labeling, holding, and distributing articles of food in accordance with this Decree, the
`
`8
`
`

`

`Case 1:22-cv-00441-HYJ-SJB ECF No. 8, PageID.70 Filed 05/16/22 Page 9 of 33
`
`Act, and its implementing regulations; and (2) will be continuously maintained in a sanitary
`
`condition;
`
`C.
`
`Defendants shall ensure that the Expert retained under paragraph 8(A):
`
`(1) Reviews all FDA inspectional observations of deficiencies at the
`
`Sturgis Facility identified in the FDA Form-483 issued on March 18, 2022, and all records
`
`related to the detection of Cronobacter spp. and/or Salmonella spp. in the environment or in-
`
`process or finished product at the Sturgis Facility from September 2019 to the present;
`
`(2) Reviews, and modifies as necessary, Defendants’ written sanitation
`
`procedures including, but not limited to, sanitation standard operating procedures for receiving,
`
`manufacturing, processing, preparing, packing, holding, and distributing articles of food
`
`(“Sanitation Plan”) to verify that the Sanitation Plan complies with the CGMP Regulations for
`
`Human Food and the Infant Formula CGMP Regulations and adequately: (a) establishes
`
`sanitation controls, monitoring procedures, and corrective actions for: (i) manufacturing
`
`processes; (ii) cleaning (including, but not limited to, cleaning in place), sanitizing, and dry-out
`
`operations (including, but not limited to, verified dry-out procedures and validated test methods
`
`for dry-out of production equipment and processing environments); and (iii) facilities (including,
`
`but not limited to, building construction and maintenance to ensure, among other things,
`
`adequate water management) and equipment and utensils contained therein; (b) addresses the
`
`risks of microbiological contamination from contaminants including, but not limited to,
`
`pathogens such as Cronobacter sakazakii and Salmonella spp.; and (c) protects against the
`
`contamination of food and food-contact surfaces and prevents insanitary conditions at the Sturgis
`
`Facility;
`
`9
`
`

`

`Case 1:22-cv-00441-HYJ-SJB ECF No. 8, PageID.71 Filed 05/16/22 Page 10 of 33
`
`(3)
`
`Reviews, and modifies as necessary, Defendants’ written
`
`environmental monitoring and testing program (“Environmental Monitoring Plan”) to verify that
`
`the Environmental Monitoring Plan complies with the requirements in paragraph 11(G);
`
`(4)
`
`Reviews, and modifies as necessary, Defendants’ written product
`
`sampling and testing program (“Product Monitoring Plan”) to verify that the Product Monitoring
`
`Plan complies with the requirements in paragraph 11(H);
`
`(5)
`
`Reviews, and modifies as necessary, Defendants’ written employee
`
`training program (“Employee Training Program”) (in English and any other language necessary
`
`to effectively convey the substance of the training) that addresses: (a) maintaining sanitation,
`
`conducting adequate sampling and analysis, avoiding bacterial contamination, and controlling
`
`pathogens; and (b) the CGMP Regulations for Human Food and the Infant Formula CGMP
`
`Regulations, and the requirements in the Sanitation Plan, the Environmental Monitoring Plan,
`
`and the Product Monitoring Plan. The Employee Training Program shall include training for
`
`new employees and ongoing training programs for existing employees;
`
`(6)
`
`Conducts a comprehensive inspection at the Sturgis Facility
`
`(including, but not limited to, buildings and equipment and utensils contained therein) and the
`
`methods, processes, and controls used to manufacture, process, prepare, pack, label, hold, and
`
`distribute articles of food, and certifies in writing to FDA that:
`
`(a)
`
`He or she has evaluated the results of environmental
`
`monitoring tests, and inspected the Sturgis Facility (including, but not limited to, buildings and
`
`equipment and utensils contained therein) and the methods, processes, and controls used to
`
`manufacture, process, prepare, pack, label, hold, and distribute articles of food;
`
`10
`
`

`

`Case 1:22-cv-00441-HYJ-SJB ECF No. 8, PageID.72 Filed 05/16/22 Page 11 of 33
`
`(b)
`
`Defendants have corrected all deficiencies at the Sturgis
`
`Facility identified in the FDA Form-483 issued on March 18, 2022, and any deficiencies
`
`identified during the Expert’s record review of the detection of Cronobacter spp. and/or
`
`Salmonella spp. in the environment or in any article of food at the Sturgis Facility (including
`
`samples collected during production under Specialty Operations), from September 2019 to the
`
`present, specifying each deficiency and Defendants’ corrections thereof. Where applicable, the
`
`Expert may refer to any completed or ongoing action described in Defendants’ Form FDA-483
`
`Response; and
`
`(c)
`
`Based on the Expert’s review and inspection, Defendants’
`
`facilities, methods, processes, and controls (including the Sanitation Plan, the Environmental
`
`Monitoring Plan, and the Product Monitoring Plan) are: (i) in compliance with this Decree, the
`
`Act, and its implementing regulations; and (ii) adequate to ensure that Defendants’ products are
`
`manufactured, processed, prepared, packed, labeled, held, and distributed in compliance with this
`
`Decree, the Act, the CGMP Regulations for Human Food, and the Infant Formula CGMP
`
`Regulations; and
`
`(7)
`
`Prepares and submits in writing to FDA a detailed report of all
`
`findings, with supporting documentation, and submits the certification, detailed report, and
`
`supporting documentation to Defendants and FDA concurrently, within fifteen days after
`
`completing the inspection; and
`
`D.
`
`Defendants shall provide to FDA an affidavit of compliance, signed by a
`
`person with personal knowledge of the facts, stating the fact and manner of compliance with the
`
`provisions of paragraphs 9(A) and 9(B). Defendants shall also submit the Sanitation Plan, the
`
`Environmental Monitoring Plan, the Product Monitoring Plan, and the Employee Training
`
`11
`
`

`

`Case 1:22-cv-00441-HYJ-SJB ECF No. 8, PageID.73 Filed 05/16/22 Page 12 of 33
`
`Program certified by the Expert pursuant to this paragraph to FDA for review and concurrence,
`
`and receive written notification of concurrence from FDA. Within twenty days after receipt of
`
`the Expert-certified plans (the Sanitation Plan, the Environmental Monitoring Plan, the Product
`
`Monitoring Plan, and the Employee Training Program), unless FDA determines that a longer
`
`time frame is necessary, in which case FDA can give Defendants notice that FDA needs an
`
`additional twenty days to complete its review, FDA will review the Expert-certified plans and
`
`provide written notification to Defendants either concurring with the plans or explaining the
`
`basis for FDA’s decision not to concur with any plan(s), including the concerns with Defendants’
`
`submission. After addressing all concerns described in FDA’s written notification of a decision
`
`not to concur, Defendants shall submit a revised plan to FDA for review and concurrence.
`
`Within fifteen days after receipt of a revised plan, unless FDA determines that a longer time
`
`frame is necessary, in which case FDA can give Defendants notice that FDA needs an additional
`
`fifteen days to complete its review, FDA will review the revised plan and provide written
`
`notification to Defendants either concurring with the revised plan or explaining the basis for
`
`FDA’s decision not to concur with the revised plan, including the concerns with Defendants’
`
`submission. This process shall be repeated until Defendants receive written notification of
`
`concurrence from FDA. In no circumstance shall FDA’s silence be construed as a substitute for
`
`written notification.
`
`General Provisions
`
`10.
`
`Subject to the exception described in this paragraph, within twenty-five days after
`
`entry of this Decree, Defendants shall destroy all articles of food that Defendants recalled prior
`
`to the date of entry of this Decree (“recalled articles”). Defendants shall give notice to FDA that,
`
`under FDA’s supervision, Defendants are prepared to destroy the recalled articles and shall
`
`12
`
`

`

`Case 1:22-cv-00441-HYJ-SJB ECF No. 8, PageID.74 Filed 05/16/22 Page 13 of 33
`
`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 destruction. In no circumstance shall FDA’s silence be construed as a
`
`substitute for written notification. Within fifteen days after receiving authorization from FDA to
`
`commence destruction, Defendants shall, under FDA supervision, complete destruction in
`
`compliance with this provision. Defendants shall not dispose of any recalled article 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 recalled articles are disposed. Defendants
`
`shall bear the costs of destruction and the costs of FDA’s supervision at the rates specified in
`
`paragraph 17. To the extent that Defendants are under a separate legal obligation to preserve all
`
`or a portion of the recalled products, Defendants shall be permitted to segregate and retain such
`
`recalled products for the duration of such preservation obligation.
`
`11.
`
`After receiving written concurrence from FDA under paragraph 9(D), Defendants
`
`shall continuously and effectively comply with the following requirements:
`
`A.
`
`Defendants shall immediately implement and follow the Sanitation Plan,
`
`the Environmental Monitoring Plan, and the Product Monitoring Plan approved by FDA under
`
`paragraph 9(D) and shall ensure that all powdered products at the Sturgis Facility are produced
`
`under conditions and practices that comply with these plans and the remaining provisions of this
`
`Decree;
`
`B.
`
`Prior to distribution of each product lot, Defendants shall ensure that a
`
`qualified individual in Defendants’ quality unit reviews the batch record, the test results for in-
`
`process and finished product, and the environmental monitoring results that pertain to the
`
`product lot, and certifies in writing that such lot meets all specifications. Defendants shall
`
`13
`
`

`

`Case 1:22-cv-00441-HYJ-SJB ECF No. 8, PageID.75 Filed 05/16/22 Page 14 of 33
`
`maintain copies of all certifications required by this paragraph at the Sturgis Facility, in a
`
`location where the certifications are readily available for reference and inspection by FDA;
`
`C. Within two days after receiving FDA’s written notification under
`
`paragraph 9(D), Defendants shall assign continuing responsibility for implementing and
`
`monitoring the FDA-approved Sanitation, Environmental Monitoring, and Product Monitoring
`
`Plans to a person(s) who, by reason of education, training, or experience, is qualified to maintain
`
`the Sturgis Facility in a sanitary condition and implement appropriate corrective actions, and
`
`Defendants provide such person(s) with the authority and resources to achieve any necessary
`
`corrective action. Defendants shall provide to FDA, in writing, the identities, titles, and
`
`qualifications of the individual(s) assigned responsibility under this paragraph within ten days
`
`after assigning responsibility to such individuals;
`
`D. Within ten days after receiving FDA’s written notification under
`
`paragraph 9(D), Defendants shall ensure that the FDA-approved Sanitation, Environmental
`
`Monitoring, and Product Monitoring Plans are available and accessible (in English and any other
`
`language necessary to effectively convey the substance of these documents) to their officers,
`
`employees, and all other persons who perform duties at the Sturgis Facility;
`
`E. Within twenty days after receiving FDA’s written notification under
`
`paragraph 9(D), Defendants shall train their employees, and all other persons who perform duties
`
`at the Sturgis Facility, in accordance with the FDA-approved Employee Training Program, to
`
`ensure that the individuals who receive, manufacture, process, prepare, pack, label, hold, or
`
`distribute articles of food are qualified to perform their assigned duties. Defendants shall submit
`
`documentation to FDA demonstrating that they have adequately trained all persons who perform
`
`duties at the Sturgis Facility in accordance with the Employee Training Program;
`
`14
`
`

`

`Case 1:22-cv-00441-HYJ-SJB ECF No. 8, PageID.76 Filed 05/16/22 Page 15 of 33
`
`F.
`
`Defendants shall provide training to each new employee within five days
`
`after the new employee commences duties at the Sturgis Facility, and provide ongoing training
`
`programs for existing employees, in accordance with the FDA-approved Employee Training
`
`Program;
`
`G.
`
`Defendants shall conduct environmental monitoring and testing in
`
`accordance with the Environmental Monitoring Plan to demonstrate that the Sanitation Plan is
`
`consistently followed to provide systematic control over pathogens, including Cronobacter spp.
`
`and Salmonella spp., to prevent contamination of finished products. Defendants’ Environmental
`
`Monitoring Plan shall conform to the following requirements:
`
`(1) Environmental monitoring shall include, but not be limited to: (a)
`
`collecting samples from equipment and production areas that may pose a high risk of
`
`contamination; other environmental sites where food is received, manufactured, processed,
`
`prepared, packed, labeled, held, or distributed; and additional areas that may be reservoirs for
`
`cross-contamination; (b) analyzing samples in an industry-recognized method that is acceptable
`
`to FDA; (c) implementing remedial action, should any pathogen be detected in the environment,
`
`including, but not limited to, intensified sanitation measures, intensified sampling and testing
`
`measures, comprehensive investigations, and a contamination-source determination (i.e., a root-
`
`cause analysis); and (d) conducting trend analyses by a qualified analyst and reviewed by a
`
`qualified manager;
`
`(2) A majority of swabs shall be collected from Zone 2 areas (i.e.,
`
`areas in the vicinity of food contact surfaces) during both routine environmental monitoring and,
`
`when appropriate, investigative environmental monitoring. When the Sanitation Plan and/or
`
`Environmental Monitoring Plan requires or recommends equipment tear-down, Defendants shall
`
`15
`
`

`

`Case 1:22-cv-00441-HYJ-SJB ECF No. 8, PageID.77 Filed 05/16/22 Page 16 of 33
`
`ensure that swabs are collected from Zone 1 (i.e., food-contact surfaces): (a) after such
`
`equipment is disassembled, before being cleaned and sanitized; and (b) after the equipment is
`
`cleaned and sanitized. Defendants shall also ensure that, if any Cronobacter spp. or Salmonella
`
`spp. is detected in a Zone 3 environment (i.e., areas surrounding Zone 2 areas), additional swabs
`
`are collected from surrounding Zone 2 areas;
`
`(3)
`
`If any Cronobacter spp. is detected in the environment, Defendants
`
`shall speciate each Cronobacter spp. isolate to determine whether it is Cronobacter sakazakii,
`
`and forward each Cronobacter sakazakii-positive test result to FDA within twenty-four hours of
`
`receipt by Defendants; and
`
`(4) Defendants shall retain each Cronobacter sakazakii and
`
`Salmonella spp. isolate under appropriate storage conditions for three years from the date of the
`
`test result detecting the presence of Cronobacter sakazakii and/or Salmonella spp. in that isolate,
`
`and each isolate is to be provided to FDA within five days of receipt of written request;
`
`H.
`
`Defendants shall conduct product monitoring and testing in accordance
`
`with the Product Monitoring Plan, to ensure that controls are adequate to prevent contamination
`
`by pathogens, including Cronobacter spp. and Salmonella spp. Defendants’ Product Monitoring
`
`Plan shall conform to the following requirements:
`
`(1) At a minimum, Defendants shall test representative samples from
`
`the beginning, middle, and end (i.e., three separate sampling periods) of each lot of each batch of
`
`finished product; and
`
`(2) The Product Monitoring Plan shall include remedial action to be
`
`implemented should any Cronobacter spp. or Salmonella spp. be detected in any article of food
`
`(including raw ingredients and in-process and finished product batches). As part of the Product
`
`16
`
`

`

`Case 1:22-cv-00441-HYJ-SJB ECF No. 8, PageID.78 Filed 05/16/22 Page 17 of 33
`
`Monitoring Plan’s remedial action, if any test of in-process or finished product detects the
`
`presence of Cronobacter spp. and/or Salmonella spp., Defendants shall:
`
`(a)
`
`Cease production at the earliest time practicable and, in any
`
`event, no later than the completion of any batch then in progress, dispose of the affected in-
`
`process and/or finished product batch, conduct a thorough contamination-source determination
`
`(i.e., root-cause analysis), adequately remediate the processing equipment and environment, and
`
`conduct intensified sanitation measures and intensified sampling and testing measures.
`
`Defendants shall maintain records of all these steps and shall make those records available to
`
`FDA immediately upon request. After a cessation of production pursuant to this paragraph,
`
`Defendants shall not resume production unless and until they receive written notice from FDA
`
`that Defendants may resume production. Within fifteen days after receipt of Defendants’ written
`
`request to resume production, unless FDA determines that, based on the complexity of the issues,
`
`a longer time frame is necessary, in which case FDA can give Defendants notice that FDA needs
`
`an additional fifteen days to complete its review, FDA will review Defendants’ r

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket