`
`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
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`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
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`or causing to be introduced, or delivering or causing to be delivered for introduction, into
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`interstate commerce articles of food that are adulterated within the meaning of 21 U.S.C.
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`§ 342(a)(4).
`
`4.
`
`The Complaint alleges that Defendants violate 21 U.S.C. § 331(a) by introducing
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`or causing to be introduced, or delivering or causing to be delivered for introduction, into
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`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
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`articles of food that are held for sale after shipment of one or more of their components in
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`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
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`articles of food, namely infant formula as defined in 21 U.S.C. § 321(z), that are held for sale
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`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
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`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
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`manufacture, processing, preparing, packing, labeling, holding, or distribution of articles of food
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`covered by paragraph 7(F) or paragraph 7(G) at or from the Sturgis Facility;
`
`B.
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`“CGMP Regulations for Human Food” shall refer to the current good
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`manufacturing practice requirements in Subpart B of 21 C.F.R. Part 117 (Current Good
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`2
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`Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human
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`Food);
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`C.
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`D.
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`“Days” shall refer to business days;
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`“Infant Formula CGMP Regulations” shall refer to the current good
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`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,
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`Quality Factors, Records and Reports, and Notifications);
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`E.
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`“Inventory Products” shall refer only to the non-recalled powdered
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`finished products manufactured at the Sturgis Facility and in Defendants’ possession, custody, or
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`control as of March 18, 2022, the close of FDA’s inspection at Defendants’ facilities located at
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`901 North Centerville Road, Sturgis, Michigan 49091;
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`F.
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`“Other Operations” shall refer to Defendants’ manufacture, processing,
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`preparing, packing, labeling, holding, and/or distribution at or from the Sturgis Facility of any
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`infant formula, as that term is defined in 21 U.S.C. § 321(z), in powdered form, except for
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`Inventory Products defined in paragraph 7(E) and products subject to Specialty Operations
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`described in paragraph 7(G);
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`G.
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`“Specialty Operations” shall refer to Defendants’ manufacture, processing,
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`preparing, packing, labeling, holding, and/or distribution at or from the Sturgis Facility of any
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`article of food that is:
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`or
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`(1) Any powdered infant formula covered by 21 U.S.C. § 350a(h)(1);
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`3
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`(2) Any powdered product for non-infants (older than 12 months of
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`age) that serves similar nutritional purposes as any formulation of powdered infant formula
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`covered by 21 U.S.C. § 350a(h)(1); and
`
`H.
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`“Sturgis Facility” shall refer to the facilities located at 901 North
`
`Centerville Road, Sturgis, Michigan 49091.
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`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
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`restrained and enjoined under 21 U.S.C. § 332(a), and the inherent equitable authority of this
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`Court, from conducting Specialty Operations, unless all the following conditions are met:
`
`A.
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`Defendants, at their expense, shall retain or continue retention of an
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`independent person or persons (“Expert”) who is without any personal or financial ties (other
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`than a retention agreement or agreements to satisfy the requirements of this Decree and/or to
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`perform other consulting or testing work for Abbott Nutrition) to Defendants or their families,
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`and who, by reason of training, education, and experience, is qualified to:
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`(1) Evaluate the facilities, methods, processes, and controls at the
`
`Sturgis Facility to ensure that Defendants’ products are manufactured, processed, prepared,
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`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
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`(2)
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`Inspect the Sturgis Facility to determine whether Defendants’
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`facilities, methods, processes, and controls are continuously operated and administered in
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`conformity with this Decree, the Act, and its implementing regulations;
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`4
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`B.
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`Defendants shall notify FDA in writing of the identity and qualifications
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`of the Expert within two days after retaining the Expert, and, in coordination with the Expert,
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`Defendants shall:
`
`(1)
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`Verify the dry-out procedures (including time and temperature
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`controls) for production equipment and processing environments, and validate the test method
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`for moisture verification used to assess dryness after the dry-out procedures for production
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`equipment and processing environments. Where applicable, Defendants may rely on completed
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`action described in Defendants’ response(s) to the FDA Form-483 issued on March 18, 2022
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`(“Form-483 Response”);
`
`(2)
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`Conduct pre-production cleaning, sanitizing, and dry-out of
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`production equipment and processing environments (using the verified dry-out procedures and
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`the validated test method), followed by environmental testing for pathogens in the processing
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`environment. Where applicable, Defendants may rely on completed actions already conducted in
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`coordination with the Expert or as described in Defendants’ Form-483 Response; and
`
`(3)
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`Prior to initiating production pursuant to paragraph 8, provide FDA
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`with the Expert’s report documenting completion of the verification and validation activities and
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`pre-production review set out in paragraph 8(B);
`
`C.
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`If Defendants choose to restrict Specialty Operations to specified
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`equipment and processing environments, then Defendants shall ensure that any cleaning,
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`sanitizing, dry-out, and/or environmental testing during the pendency of Specialty Operations of
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`equipment and processing environments that are not part of Specialty Operations is
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`accomplished in a manner that protects against contamination of the specified equipment and
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`processing environments (and utensils therein) that are part of Specialty Operations;
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`5
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`D.
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`Defendants shall, as and when feasible, prioritize production in a manner
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`that minimizes the risk of market disruption;
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`E.
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`Prior to distribution of each product lot produced during Specialty
`
`Operations, Defendants shall ensure that a qualified individual in Defendants’ quality unit
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`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
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`that such lot meets all specifications;
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`F.
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`Defendants shall ensure that environmental monitoring during Specialty
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`Operations consists of routine sampling and, when appropriate, investigative sampling, and that a
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`qualified individual in Defendants’ quality unit conducts trending analyses of environmental
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`monitoring results from both routine and investigative sampling;
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`G.
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`Defendants shall collect in-process and finished product samples during
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`Specialty Operations and shall analyze the powdered infant formula samples for Cronobacter
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`spp. and Salmonella spp., in the manner specified in 21 C.F.R. § 106.55, and shall analyze the
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`powdered non-infant product samples for Salmonella spp. If any test of in-process or finished
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`product detects the presence of Cronobacter spp. and/or Salmonella spp., Defendants shall:
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`(1) Cease production at the earliest time practicable and, in any event,
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`no later than the completion of any batch then in progress, dispose of the affected in-process
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`and/or finished product batch, conduct a thorough contamination-source determination (i.e., root-
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`cause analysis), and adequately remediate the processing equipment and environment.
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`Defendants shall maintain records of all the steps taken pursuant to this paragraph and shall
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`make the records available to FDA immediately upon request. After a cessation of production
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`pursuant to this paragraph, Defendants shall not resume production unless and until they receive
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`6
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`written notice from FDA that Defendants may resume production. Within fifteen days after
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`receipt of Defendants’ written request to resume production, unless FDA determines that, based
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`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
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`review Defendants’ request to resume production and provide written notification to Defendants
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`either permitting resumption or explaining the basis for FDA’s decision not to permit resumption
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`of production, including the concerns with Defendants’ submission. After addressing all
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`concerns described in FDA’s written notification of a decision not to permit resumption,
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`Defendants may submit a new request to resume production, and the process described in
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`paragraph 8(G)(1) shall be repeated until Defendants receive written notification from FDA that
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`they may resume production. In no circumstance shall FDA’s silence be construed as a
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`substitute for written notification;
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`(2)
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`Forward the test results detecting the presence of Cronobacter spp.
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`and/or Salmonella spp. in in-process and/or finished product to FDA within twenty-four hours
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`after receipt by Defendants (along with a written statement confirming that Defendants have
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`ceased production in accordance with paragraph 8(G)(1)), speciate each Cronobacter spp. isolate
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`to determine whether it is Cronobacter sakazakii, and forward each Cronobacter sakazakii-
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`positive test result to FDA within twenty-four hours of receipt by Defendants; and
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`(3) Retain each Cronobacter sakazakii and Salmonella spp. isolate
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`under appropriate storage conditions for three years from the date of the test result detecting the
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`presence of Cronobacter sakazakii and/or Salmonella spp. in that isolate, and each isolate is to
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`be provided to FDA within five days of receipt of a written request;
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`7
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`H.
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`Defendants shall maintain a record of all sales and distribution of
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`products, including shipping documents and the following information for the product
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`distributed: the product name; the product size and configuration if variations exist; the batch,
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`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
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`this paragraph available to FDA immediately upon request; and
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`I.
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`Defendants shall, in accordance with the procedures in paragraph 10,
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`destroy all Inventory Products defined in paragraph 7(E) that have not been distributed within
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`fifteen days after Defendants initiate production under Specialty Operations. The parties may
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`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
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`segregate and retain such Inventory Products for the duration of such preservation obligation.
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`Other Operations
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`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.
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`Defendants shall ensure that the Sturgis Facility and equipment therein:
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`(1) are cleaned and sanitized to render them suitable for manufacturing, processing, preparing,
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`packing, labeling, holding, and distributing articles of food in accordance with this Decree, the
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`8
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`Act, and its implementing regulations; and (2) will be continuously maintained in a sanitary
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`condition;
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`C.
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`Defendants shall ensure that the Expert retained under paragraph 8(A):
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`(1) Reviews all FDA inspectional observations of deficiencies at the
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`Sturgis Facility identified in the FDA Form-483 issued on March 18, 2022, and all records
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`related to the detection of Cronobacter spp. and/or Salmonella spp. in the environment or in-
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`process or finished product at the Sturgis Facility from September 2019 to the present;
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`(2) Reviews, and modifies as necessary, Defendants’ written sanitation
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`procedures including, but not limited to, sanitation standard operating procedures for receiving,
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`manufacturing, processing, preparing, packing, holding, and distributing articles of food
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`(“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
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`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
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`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
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`risks of microbiological contamination from contaminants including, but not limited to,
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`pathogens such as Cronobacter sakazakii and Salmonella spp.; and (c) protects against the
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`contamination of food and food-contact surfaces and prevents insanitary conditions at the Sturgis
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`Facility;
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`(3)
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`Reviews, and modifies as necessary, Defendants’ written
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`environmental monitoring and testing program (“Environmental Monitoring Plan”) to verify that
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`the Environmental Monitoring Plan complies with the requirements in paragraph 11(G);
`
`(4)
`
`Reviews, and modifies as necessary, Defendants’ written product
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`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
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`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
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`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
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`(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;
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`10
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`(b)
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`Defendants have corrected all deficiencies at the Sturgis
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`Facility identified in the FDA Form-483 issued on March 18, 2022, and any deficiencies
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`identified during the Expert’s record review of the detection of Cronobacter spp. and/or
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`Salmonella spp. in the environment or in any article of food at the Sturgis Facility (including
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`samples collected during production under Specialty Operations), from September 2019 to the
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`present, specifying each deficiency and Defendants’ corrections thereof. Where applicable, the
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`Expert may refer to any completed or ongoing action described in Defendants’ Form FDA-483
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`Response; and
`
`(c)
`
`Based on the Expert’s review and inspection, Defendants’
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`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
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`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
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`Decree, the Act, the CGMP Regulations for Human Food, and the Infant Formula CGMP
`
`Regulations; and
`
`(7)
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`Prepares and submits in writing to FDA a detailed report of all
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`findings, with supporting documentation, and submits the certification, detailed report, and
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`supporting documentation to Defendants and FDA concurrently, within fifteen days after
`
`completing the inspection; and
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`D.
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`Defendants shall provide to FDA an affidavit of compliance, signed by a
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`person with personal knowledge of the facts, stating the fact and manner of compliance with the
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`provisions of paragraphs 9(A) and 9(B). Defendants shall also submit the Sanitation Plan, the
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`Environmental Monitoring Plan, the Product Monitoring Plan, and the Employee Training
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`11
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`Program certified by the Expert pursuant to this paragraph to FDA for review and concurrence,
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`and receive written notification of concurrence from FDA. Within twenty days after receipt of
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`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.
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`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.
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`General Provisions
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`10.
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`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
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`specify the proposed time, place, and method of destruction. Defendants shall not commence, or
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`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
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`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
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`contrary to the provisions of the Act, any other federal law, any court order, or the laws of any
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`state or Territory, as defined in the Act, in which the recalled articles are disposed. Defendants
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`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
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`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.
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`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
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`maintain copies of all certifications required by this paragraph at the Sturgis Facility, in a
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`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;
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`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;
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`14
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`F.
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`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
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`programs for existing employees, in accordance with the FDA-approved Employee Training
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`Program;
`
`G.
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`Defendants shall conduct environmental monitoring and testing in
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`accordance with the Environmental Monitoring Plan to demonstrate that the Sanitation Plan is
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`consistently followed to provide systematic control over pathogens, including Cronobacter spp.
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`and Salmonella spp., to prevent contamination of finished products. Defendants’ Environmental
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`Monitoring Plan shall conform to the following requirements:
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`(1) Environmental monitoring shall include, but not be limited to: (a)
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`collecting samples from equipment and production areas that may pose a high risk of
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`contamination; other environmental sites where food is received, manufactured, processed,
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`prepared, packed, labeled, held, or distributed; and additional areas that may be reservoirs for
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`cross-contamination; (b) analyzing samples in an industry-recognized method that is acceptable
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`to FDA; (c) implementing remedial action, should any pathogen be detected in the environment,
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`including, but not limited to, intensified sanitation measures, intensified sampling and testing
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`measures, comprehensive investigations, and a contamination-source determination (i.e., a root-
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`cause analysis); and (d) conducting trend analyses by a qualified analyst and reviewed by a
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`qualified manager;
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`(2) A majority of swabs shall be collected from Zone 2 areas (i.e.,
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`areas in the vicinity of food contact surfaces) during both routine environmental monitoring and,
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`when appropriate, investigative environmental monitoring. When the Sanitation Plan and/or
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`Environmental Monitoring Plan requires or recommends equipment tear-down, Defendants shall
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`ensure that swabs are collected from Zone 1 (i.e., food-contact surfaces): (a) after such
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`equipment is disassembled, before being cleaned and sanitized; and (b) after the equipment is
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`cleaned and sanitized. Defendants shall also ensure that, if any Cronobacter spp. or Salmonella
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`spp. is detected in a Zone 3 environment (i.e., areas surrounding Zone 2 areas), additional swabs
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`are collected from surrounding Zone 2 areas;
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`(3)
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`If any Cronobacter spp. is detected in the environment, Defendants
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`shall speciate each Cronobacter spp. isolate to determine whether it is Cronobacter sakazakii,
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`and forward each Cronobacter sakazakii-positive test result to FDA within twenty-four hours of
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`receipt by Defendants; and
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`(4) Defendants shall retain each Cronobacter sakazakii and
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`Salmonella spp. isolate under appropriate storage conditions for three years from the date of the
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`test result detecting the presence of Cronobacter sakazakii and/or Salmonella spp. in that isolate,
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`and each isolate is to be provided to FDA within five days of receipt of written request;
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`H.
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`Defendants shall conduct product monitoring and testing in accordance
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`with the Product Monitoring Plan, to ensure that controls are adequate to prevent contamination
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`by pathogens, including Cronobacter spp. and Salmonella spp. Defendants’ Product Monitoring
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`Plan shall conform to the following requirements:
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`(1) At a minimum, Defendants shall test representative samples from
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`the beginning, middle, and end (i.e., three separate sampling periods) of each lot of each batch of
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`finished product; and
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`(2) The Product Monitoring Plan shall include remedial action to be
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`implemented should any Cronobacter spp. or Salmonella spp. be detected in any article of food
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`(including raw ingredients and in-process and finished product batches). As part of the Product
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`Monitoring Plan’s remedial action, if any test of in-process or finished product detects the
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`presence of Cronobacter spp. and/or Salmonella spp., Defendants shall:
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`(a)
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`Cease production at the earliest time practicable and, in any
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`event, no later than the completion of any batch then in progress, dispose of the affected in-
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`process and/or finished product batch, conduct a thorough contamination-source determination
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`(i.e., root-cause analysis), adequately remediate the processing equipment and environment, and
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`conduct intensified sanitation measures and intensified sampling and testing measures.
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`Defendants shall maintain records of all these steps and shall make those records available to
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`FDA immediately upon request. After a cessation of production pursuant to this paragraph,
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`Defendants shall not resume production unless and until they receive written notice from FDA
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`that Defendants may resume production. Within fifteen days after receipt of Defendants’ written
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`request to resume production, unless FDA determines that, based on the complexity of the issues,
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`a longer time frame is necessary, in which case FDA can give Defendants notice that FDA needs
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`an additional fifteen days to complete its review, FDA will review Defendants’ r