Case: 1:22-cv-01123 Document #: 7 Filed: 03/07/22 Page 1 of 26 PageID #:56
`ILND 450 (Rev. 10/13) Judgment in a Civil Action
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE
`NORTHERN DISTRICT OF ILLINOIS
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`Case No. 22 C 1123
`Judge Edmond E. Chang
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`USA,
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`Plaintiff(s),
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`v.
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`Salud Natural Entrepreneur, Inc., et al.,
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`Defendant(s).
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`JUDGMENT IN A CIVIL CASE
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`Judgment is hereby entered (check appropriate box):
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`This action was (check one):
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`in favor of plaintiff(s)
`and against defendant(s)
`in the amount of $ ,
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`which
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` includes pre–judgment interest.
` does not include pre–judgment interest.
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`Post-judgment interest accrues on that amount at the rate provided by law from the date of this judgment.
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`Plaintiff(s) shall recover costs from defendant(s).
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`in favor of defendant(s)
`and against plaintiff(s)
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` Defendant(s) shall recover costs from plaintiff(s).
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`other: Consent decree entered.
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` tried by a jury with Judge presiding, and the jury has rendered a verdict.
` tried by Judge without a jury and the above decision was reached.
` decided by Judge Edmond E. Chang.
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`Date: 3/7/2022
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`Thomas G. Bruton, Clerk of Court
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`/s/ Michael Wing, Deputy Clerk
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`Case: 1:22-cv-01123 Document #: 7 Filed: 03/07/22 Page 2 of 26 PageID #:57
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`UNITED STATES OF AMERICA,
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`Plaintiff,
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`v.
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`SALUD NATURAL ENTREPRENEUR,
`INC., a corporation
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`UNITED STATES DISTRICT COURT
`NORTHERN DISTRICT OF ILLINOIS
`EASTERN DIVISION
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`No. 1:22-CV-01123
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`Judge Edmond E. Chang
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`and
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`HECTOR PABLO OLIVA, MICHEL
`MONFORT, and CAROLINA L. GIRAL,
`individuals,
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`Defendants.
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`CONSENT DECREE
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`Plaintiff, the United States of America, by its undersigned attorneys, having filed a
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`complaint for permanent injunction against Salud Natural Entrepreneur, Inc. (“Salud Natural”), a
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`corporation, and Hector Pablo Oliva, Michel Monfort, and Carolina Giral, individuals
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`(collectively, “Defendants”), and Defendants having appeared by their attorney and consented to
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`entry of this consent decree for permanent Injunction (the “Decree”) without contest and before
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`any testimony has been taken, and the United States of America having consented to this Decree;
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`it is hereby
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` ORDERED, ADJUDGED, and DECREED that:
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`1.
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`2.
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`This court has jurisdiction over the subject matter and all parties to this action.
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`The complaint for permanent injunction states a cause of action against Defendants
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`under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301, et seq. (the “Act”).
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`3.
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`Defendants violate the Act, 21 U.S.C. § 331(a), by introducing or delivering for
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`introduction, and/or causing to be introduced or delivered for introduction, into interstate
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`Case: 1:22-cv-01123 Document #: 7 Filed: 03/07/22 Page 3 of 26 PageID #:58
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`commerce articles of food (dietary supplements, as defined at 21 U.S.C. § 321(ff)) that are
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`adulterated within the meaning of 21 U.S.C. § 342(g)(1) in that they have been prepared, packed,
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`or held in violation of the current good manufacturing practice regulations for dietary supplements
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`set forth in 21 C.F.R. Part 111 (“Dietary Supplement CGMP”).
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`4.
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`Defendants violate the Act, 21 U.S.C. § 331(k), by causing articles of food (dietary
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`supplements, as defined at 21 U.S.C. § 321(ff)) that Defendants hold for sale after shipment of one
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`or more of their components in interstate commerce to become adulterated within the meaning of
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`21 U.S.C. § 342(g)(1).
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`5.
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`Defendants violate the Act, 21 U.S.C. § 331(a), by introducing or delivering for
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`introduction, and/or causing to be introduced or delivered for introduction, into interstate
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`commerce articles of food (dietary supplements, as defined at 21 U.S.C. §321(ff)) that are
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`misbranded within the meaning of 21 U.S.C. §§ 343(f), (q)(1)(A), (q)(5)(F), (r)(1)(A),
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`(s)(2)(A)(ii), and/or (s)(2)(C).
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`6.
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`Defendants violate the Act, 21 U.S.C. § 331(k), by causing articles of food (dietary
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`supplements, as defined in 21 U.S.C. § 321(ff)) that Defendants hold for sale after shipment of one
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`or more of their components in interstate commerce to become misbranded within the meaning of
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`21 U.S.C. §§ 343(f), (q)(1)(A), (q)(5)(F), (r)(1)(A), (s)(2)(A)(ii), and/or (s)(2)(C).
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`7.
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`Defendants violate the Act, 21 U.S.C. § 331(d), by introducing or delivering for
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`introduction, and/or causing to be introduced or delivered for introduction, into interstate
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`commerce new drugs (as defined in 21 U.S.C. § 321(p)), that are neither approved pursuant to
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`21 U.S.C. § 355 nor exempt from approval.
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`8.
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`Defendants violate the Act, 21 U.S.C. § 331(a), by introducing or delivering for
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`introduction, and/or causing to be introduced or delivered for introduction, into interstate
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`2
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`Case: 1:22-cv-01123 Document #: 7 Filed: 03/07/22 Page 4 of 26 PageID #:59
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`commerce articles of drug (as defined by 21 U.S.C. § 321(g)(1)(B)), that are misbranded within
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`the meaning of 21 U.S.C. § 352(f)(1).
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`9.
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`Defendants violate the Act, 21 U.S.C. § 331(k), by causing articles of drug (as
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`defined by 21 U.S.C. § 321(g)(1)(B)), that Defendants hold for sale after shipment of one or more
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`of their components in interstate commerce to become misbranded within the meaning of 21
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`U.S.C. § 352(f)(1).
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`10.
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`Upon entry of this Decree, Defendants and each and all of their directors, officers,
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`agents, representatives, employees, attorneys, successors and assigns, and any and all persons or
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`entities in active concert or participation with any of them, who have received actual notice of this
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`Decree by personal service or otherwise, are hereby permanently restrained and enjoined under
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`21 U.S.C. § 332(a), and the inherent equitable authority of this court, from directly or indirectly
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`receiving, manufacturing, preparing, packing, repacking, labeling, holding, or distributing any
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`articles of food (including but not limited to dietary supplements and their components) and/or
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`articles of drug, at or from their facility located at 1120 Glen Rock Avenue, Waukegan, Illinois
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`60085, or at or from any other location(s) at or from which Defendants now or in the future directly
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`or indirectly receive, manufacture, prepare, pack, repack, label, hold, or distribute any articles of
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`food (including but not limited to dietary supplements and their components) and/or articles of
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`drug (hereafter, “Defendants’ Facility” or “the Facility”), unless and until:
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`A.
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`Defendants retain, at Defendants’ expense, an independent person (the
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`“CGMP Expert”) who has no personal or financial ties (other than a retention agreement)
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`to Defendants and/or their families, and who, by reason of background, training, education,
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`or experience, is qualified to inspect the Facility to determine whether the methods,
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`processes, and controls for receiving, manufacturing, preparing, packing, repacking,
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`labeling, holding, or distributing dietary supplements are operated and administered in
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`3
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`Case: 1:22-cv-01123 Document #: 7 Filed: 03/07/22 Page 5 of 26 PageID #:60
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`conformity with Dietary Supplement CGMP requirements. Defendants shall notify FDA
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`in writing of the identity and qualifications of the CGMP Expert within ten business days
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`of retaining such expert or, if Defendants already have retained a CGMP Expert, within ten
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`business days after signing this Decree;
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`B.
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`The CGMP Expert performs a comprehensive inspection of the Facility and
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`the methods, processes, and controls used to receive, manufacture, prepare, pack, repack,
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`label, hold, and distribute dietary supplements and certifies in writing to FDA that: (1) he
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`or she has inspected the Facility and the methods, processes, and controls used to receive,
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`manufacture, prepare, pack, repack, label, hold, and distribute dietary supplements; (2) all
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`Dietary Supplement CGMP deviations that have been brought to Defendants’ attention by
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`FDA, the CGMP Expert, and any other source have been corrected; and (3) the Facility
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`and the methods, processes, and controls used to receive, manufacture, prepare, pack,
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`repack, label, hold, and distribute dietary supplements are, in the CGMP Expert’s opinion,
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`in compliance with this Decree, the Act, and the Act’s implementing regulations.
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`Defendants shall ensure that the CGMP Expert prepares a detailed report of the inspection,
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`to be submitted concurrently to Defendants and FDA as part of the CGMP Expert’s
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`certification, no later than fifteen business days after completion of the inspection.
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`Defendants shall ensure that the CGMP Expert’s report includes, but is not limited to, a
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`determination that Defendants have methods, processes, and controls to ensure that
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`Defendants:
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`(1)
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`Establish and follow written procedures for the responsibilities of
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`the quality control operations, including written procedures for conducting a
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`material review and making a disposition decision, and for approving or rejecting
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`any reprocessing, as required by 21 C.F.R. § 111.103;
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`Case: 1:22-cv-01123 Document #: 7 Filed: 03/07/22 Page 6 of 26 PageID #:61
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`(2)
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`Through their quality control personnel, reject a component or
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`dietary supplement when a specification established in accordance with 21 C.F.R.
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`§ 111.70 is not met, as required by 21 C.F.R. § 113(b)(2);
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`(3)
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`Prepare and follow a written master manufacturing record for each
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`unique formulation and each batch size of dietary supplement Defendants
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`manufacture, to ensure uniformity in the finished batch and from batch to batch, as
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`required by 21 C.F.R. §§ 111.205 and 111.210. The master manufacturing record
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`must contain all information set forth in 21 C.F.R. § 111.210, including but not
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`limited to:
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`(a)
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`the name and weight of each dietary ingredient for each
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`batch size, as required by 21 C.F.R. § 111.210(a);
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`(b)
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`a complete list of components to be used, as required by 21
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`C.F.R. § 111.210(b);
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`(c)
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`an accurate statement of the weight and measure of each
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`component to be used, as required by 21 C.F.R. § 111.210(c);
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`(d)
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`the identity of each ingredient that will be declared on the
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`ingredients list, as required by 21 C.F.R. § 111.210(d);
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`(e)
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`a statement of any intentional overage amount, as required
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`by 21 C.F.R. § 111.210(e);
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`(f)
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`a statement of the theoretical yield for each point, step, or
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`stage of the manufacturing process where control is needed to ensure the
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`quality of the dietary supplement, the expected yield when manufacturing
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`of the dietary supplement is finished, and the maximum and minimum
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`percentages of theoretical yield beyond which a deviation investigation of a
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`Case: 1:22-cv-01123 Document #: 7 Filed: 03/07/22 Page 7 of 26 PageID #:62
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`batch is necessary and material review is conducted and disposition decision
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`is made, as required by 21 C.F.R. § 111.210(f);
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`(g)
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`a description of the packaging and a representative label, or
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`a cross reference to the physical location of the actual or representative
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`label, as required by 21 C.F.R. § 111.210(g);
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`(h)
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`written instructions, as required by 21 C.F.R. § 111.210(h),
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`including:
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`(i)
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`specifications for each point, step, or stage in the
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`manufacturing process where control is necessary to ensure that the
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`dietary supplement is packaged and labeled as specified in the
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`master manufacturing
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`record, as
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`required by 21 C.F.R.
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`§ 111.210(h)(1);
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`(ii)
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`procedures for sampling and a cross-reference to
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`procedures for tests or examinations, as required by 21 C.F.R.
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`§ 111.210(h)(2);
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`(iii)
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`specific actions necessary to perform and verify
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`points, steps, or stages in the manufacturing process where control
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`is necessary to ensure the quality of the dietary supplement and that
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`the dietary supplement is packaged and labeled as specified in the
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`master manufacturing record, including verifying the weight or
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`measure of any component and verifying the addition of any
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`component, as required by 21 C.F.R. § 111.210(h)(3); and
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`(iv)
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`corrective action plans for use when a specification
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`is not met, as required by 21 C.F.R. § 111.210(h)(5);
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`Case: 1:22-cv-01123 Document #: 7 Filed: 03/07/22 Page 8 of 26 PageID #:63
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`(4)
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`Prepare and follow a batch production record for each batch of
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`dietary supplements Defendants manufacture that includes complete information
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`relating to the production and control of each batch, as required by 21 C.F.R.
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`§§ 111.255 and 111.260. Batch production records must contain all information
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`set forth in 21 C.F.R. § 111.260, including but not limited to:
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`(a)
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`the identity and weight or measure of each component, as
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`required by 21 C.F.R. § 111.260(e);
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`(b)
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`documentation, at
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`the
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`time of performance, of
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`the
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`manufacture of the batch including:
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`(i)
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`the date on which each step of
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`the master
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`manufacturing record was performed, as required by 21 C.F.R.
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`§ 111.260(j)(1);
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`(ii)
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`the initials of the persons performing each step to
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`include the initials of the person responsible for weighing or
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`measuring each component used in the batch, the initials of the
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`person responsible for verifying the weight or measure of each
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`component used in the batch, the initials of the person responsible
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`for adding the component to the batch, and the initials of the person
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`verifying the addition of the components to the batch, as required by
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`21 C.F.R. § 111.260(j)(2);
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`(c)
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`documentation, at the time of performance, of packaging and
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`labeling operations, including:
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`(i)
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`the unique identifier that Defendants assigned to
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`packaging and labels used, the quantity of the packaging and labels
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`used, and, when label reconciliation is required, reconciliation of
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`any discrepancies between issuance and use of labels, as required by
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`21 C.F.R. § 111.260(k)(1);
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`(ii)
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`an actual or representative label, or a cross-reference
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`to the physical location of the actual or representative label specified
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`in the master manufacturing record, as required by 21 C.F.R.
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`§ 111.260(k)(2); and
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`(iii)
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`the results of any tests or examinations conducted on
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`packaged and labeled dietary supplements (including repackaged or
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`relabeled dietary supplements), or a cross-reference to the physical
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`location of such results, as required by 21 C.F.R. § 111.260(k)(3);
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`(d)
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`documentation, at the time of performance, that quality
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`control personnel:
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`(i)
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`reviewed each batch production record, as required
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`by 21 C.F.R. § 111.260(l)(1), including review of any monitoring
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`operations, as required by 21 C.F.R. § 111.260(l)(1)(i), and review
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`of the results of any tests and examinations, including tests and
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`examinations conducted on components, in-process materials,
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`finished dietary supplements, and packaged and labeled dietary
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`supplements, as required by 21 C.F.R. § 111.260(l)(1)(ii);
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`(ii)
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`approved or
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`rejected
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`any
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`reprocessing or
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`repackaging, as required by 21 C.F.R. § 111.260(l)(2);
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`(iii)
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`approved and released, or rejected, the batch for
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`distribution, including any reprocessed batch, as required by 21
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`C.F.R. § 111.260(l)(3); and
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`(iv)
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`approved and released, or rejected, the packaged and
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`labeled dietary supplement, including any repackaged or relabeled
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`dietary supplements, as required by 21 C.F.R. § 111.260(l)(4);
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`(e)
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`documentation, at the time of performance, of any required
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`material review or disposition decision, as required by 21 C.F.R.
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`§ 111.260(m).
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`(5) Maintain equipment to protect components and dietary supplements
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`from being contaminated by any source, as required by 21 C.F.R. § 111.27(a)(3)(v);
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`(6)
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`Take all necessary precautions during the manufacture of a dietary
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`supplement to prevent contamination of components or dietary supplements, as
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`required by 21 C.F.R. § 111.365;
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`(7)
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`Hold components and dietary supplements under appropriate
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`conditions, including temperature and humidity, so that the identity, purity,
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`strength, and composition of the components and dietary supplements are not
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`affected, as required by 21 C.F.R. § 111.455;
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`C.
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`Defendants retain, at Defendants’ expense, an independent expert (the
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`“Labeling Expert”) who is without any personal or financial ties (other than a retention
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`agreement) to Defendants and/or their families, except that this person may be the same as
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`the CGMP Expert described in paragraph 10.A., and who, by reason of background,
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`training, education, or experience, is qualified to review Defendants’ product labeling
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`(including but not limited to labels, catalogs, websites, and social media accounts) and
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`other promotional/ informational material to determine whether: (1) the labeling complies
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`with 21 U.S.C. § 343 and applicable regulations; and (2) Defendants’ claims cause any
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`product that they receive, manufacture, prepare, pack, repack, label, hold, or distribute to
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`be a drug within the meaning of 21 U.S.C. §321(g)(1). Defendants shall notify FDA in
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`writing of the identity and qualifications of the Labeling Expert within ten business days
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`of retaining such expert, or, if Defendants have already retained a Labeling Expert, within
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`ten business days after signing this Decree.
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`D.
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`The Labeling Expert conducts a comprehensive review of Defendants’
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`product labeling (including but not limited to labels, catalogs, websites, and social media
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`accounts) and other promotional/informational material and certifies in writing to FDA
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`that:
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`(1) he or she has
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`reviewed Defendants’ product
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`labeling and other
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`promotional/informational materials; (2) all labeling violations brought to Defendants’
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`attention by FDA, the Labeling Expert, and any other source, have been corrected; and (3)
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`Defendants’ products and claims are, in the Labeling Expert’s opinion, in compliance with
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`this Decree, the Act, and its implementing regulations. Defendants shall ensure that the
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`Labeling Expert prepares a detailed report of the review, to be submitted concurrently to
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`Defendants and FDA as part of the Labeling Expert’s certification, no later than fifteen
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`(15) business days after completion of the review. Defendants shall ensure that the
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`Labeling Expert’s report includes, but is not limited to, a determination that:
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`(1)
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`Defendants have implemented procedures that are adequate to
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`ensure that their product labeling complies with 21 U.S.C § 343 and applicable
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`regulations; and
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`(2)
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`Defendants have implemented procedures that are adequate to
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`ensure that their claims do not cause any product that they receive, manufacture,
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`prepare, pack, repack, label, hold, or distribute to be a drug within the meaning of
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`21 U.S.C. § 321(g)(1), unless and until the product is the subject of an approved
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`new drug application or abbreviated new drug application pursuant to 21 U.S.C.
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`§ 355(a), (b), or (j), or an investigational new drug application is in effect for such
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`product pursuant to 21 U.S.C. § 355(i);
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`E.
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`
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`Defendants report to FDA in writing the actions they have taken to:
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`(1)
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`Correct the Dietary Supplement CGMP and labeling deviations
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`brought to Defendants’ attention by FDA, the CGMP Expert, the Labeling Expert,
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`and any other source;
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`(2)
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`Ensure that the facilities, methods, processes, and controls used to
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`receive, manufacture, prepare, pack, repack, label, hold, and distribute dietary
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`supplements are and will be continuously operated in conformity with Dietary
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`Supplement CGMP;
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`(3)
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`Ensure that Defendants’ product labeling complies with 21 U.S.C.
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`§ 343 and applicable regulations; and
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`(4)
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`Ensure that Defendants’ claims do not cause any product that they
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`receive, manufacture, prepare, pack, repack, label, hold, or distribute to be a drug
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`within the meaning of 21 U.S.C. § 321(g)(1) unless the product is the subject of an
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`approved new drug application or abbreviated new drug application pursuant to 21
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`U.S.C. § 355(a), (b), or (j), or an investigational new drug application is in effect
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`for such product pursuant to 21 U.S.C. § 355((i);
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`F.
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`As and when FDA deems necessary, FDA representatives inspect
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`Defendants’ Facility, including the buildings, equipment, products, labeling, and all
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`relevant records contained therein, to determine whether the requirements of this Decree
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`have been met and whether Defendants are operating in conformity with the Act, its
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`implementing regulations, and this Decree;
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`G.
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`FDA notifies Defendants in writing that they appear to be in compliance
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`with the requirements set forth in paragraphs 10.A-E. of this Decree. In no circumstance
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`shall FDA’s silence be construed as a substitute for written notification.
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`11. Within fifteen business days after entry of this Decree, Defendants, under FDA’s
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`supervision, shall destroy all dietary supplements (including components) and/or articles of drug
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`(including raw and in-process materials and finished products) that are in Defendants’ possession,
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`custody, or control. Defendants shall bear the costs of destruction and the costs of FDA’s
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`supervision. Defendants shall not dispose of any products in a manner contrary to the provisions
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`of the Act, any other federal law, or the laws or any State or Territory, as defined in the Act, in
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`which the products are disposed.
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`12.
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`Upon resuming operations after complying with paragraphs 10.A.-E. and receiving
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`FDA’s written notification pursuant to paragraph 10.G., Defendants shall retain an independent
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`person (the “Auditor”) who shall meet the criteria for, and may be the same person as, the CGMP
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`Expert and Labeling Expert described in paragraphs 10.A. and 10.C., to conduct audit inspections
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`of the Facility and the methods, processes, and controls used to receive, manufacture, prepare,
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`pack, repack, label, hold, and distribute dietary supplements, and of Defendants’ dietary
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`supplement labeling (including but not limited to labels, catalogs, websites, and social media
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`accounts) and other promotional/informational material. Such audit inspections must entail the
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`Auditor’s physical presence at the Facility; audit inspections may not be conducted entirely by
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`virtual means (e.g., by camera or video link) without FDA’s prior approval. The first audit
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`inspection shall occur no later than six (6) months after operations resume. Thereafter:
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`A.
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`Defendants shall ensure that the Auditor conducts audit inspections no less
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`frequently than once every six months for a period of no less than five years and then at
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`least once every year thereafter. The first audit shall occur not more than six months after
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`Defendants have received FDA’s written notification pursuant to paragraph 10.G.
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`B.
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`Defendants shall ensure that, at the conclusion of each audit inspection, the
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`Auditor prepares a detailed written audit report (“Audit Report”) analyzing whether
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`Defendants are in compliance with this Decree, the Act, and its implementing regulations
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`and identifying any deviations from such requirements (“Audit Report Observations”).
`
`Defendants shall ensure that each Audit Report contains a written certification that the
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`Auditor personally inspected the Facility, the methods, processes, and controls used to
`
`receive, manufacture, prepare, pack, repack, label, hold, and distribute dietary
`
`supplements, and Defendants’ dietary supplement labeling (including but not limited to
`
`labels, catalogs, websites, and social media accounts) and other promotional/informational
`
`material, and whether Defendants are in compliance with this Decree, the Act, and its
`
`implementing regulations. Defendants shall ensure that, as a part of every Audit Report
`
`(except the first one), the Auditor assesses the adequacy of actions taken by Defendants to
`
`correct all previous Audit Report Observations. Defendants shall ensure that the Audit
`
`Reports are delivered contemporaneously to Defendants and FDA by courier service or
`
`overnight delivery service, no later than five business days after the audit inspection is
`
`completed. In addition, Defendants shall maintain the Audit Reports in separate files at
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`Defendants’ Facility and shall promptly make the Audit Reports available to FDA upon
`
`request.
`
`C.
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`If an Audit Report contains any Audit Report Observations, Defendants
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`shall, within ten business days after receipt of the Audit Report, correct those observations,
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`
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`unless FDA notifies Defendants that a shorter time period is necessary. If, after receiving
`
`the Audit Report, Defendants believe that correction of the Audit Report Observations will
`
`take longer than ten business days, Defendants shall, within five business days after receipt
`
`of the Audit Report, submit to FDA in writing a proposed schedule for completing
`
`corrections (“Audit Correction Schedule”). The Audit Correction Schedule must be
`
`reviewed and approved by FDA in writing prior to implementation by Defendants. In no
`
`circumstance shall FDA’s silence be construed as a substitute for written approval.
`
`Defendants shall complete all corrections according to the approved Audit Correction
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`Schedule. Within twenty business days after Defendants’ receipt of an Audit Report,
`
`unless FDA notifies Defendants that a shorter time period is necessary, or within the time
`
`period provided in an FDA-approved Audit Correction Schedule, the Auditor shall review
`
`the actions taken by Defendants to correct the Audit Report Observations. Within five
`
`business days after beginning that review, the Auditor shall report in writing to FDA
`
`whether each of the Audit Report Observations has been corrected and, if not, which Audit
`
`Report Observations remain uncorrected.
`
`13.
`
`Upon entry of this Decree, and after receiving FDA’s written notification pursuant
`
`to paragraph 10.G., Defendants and each and all of their directors, officers, agents, representatives,
`
`employees, attorneys, successors and assigns, and any and all persons or entities in active concert
`
`or participation with any of them, are permanently restrained and enjoined under 21 U.S.C.
`
`§ 332(a) from directly or indirectly doing or causing to be done any of the following acts:
`
`A.
`
`Violating 21 U.S.C. § 331(a) by introducing or delivering for introduction,
`
`or causing to be introduced or delivered for introduction, into interstate commerce articles
`
`of food (including but not limited to dietary supplements and their components) that are
`
`
`
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`
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`adulterated within the meaning of 21 U.S.C. § 342(g)(1) and/or misbranded within the
`
`meaning of 21 U.S.C. § 343;
`
`B.
`
`Violating 21 U.S.C. § 331(k) by causing articles of food (including but not
`
`limited to dietary supplements and their components) to become adulterated within the
`
`meaning of 21 U.S.C. § 342(g)(1) and/or misbranded within the meaning of 21 U.S.C.
`
`§ 343, while such articles are held for sale after shipment of one or more of their
`
`components in interstate commerce;
`
`C.
`
`Violating 21 U.S.C. § 331(d) by introducing or delivering for introduction,
`
`or causing to be introduced or delivered for introduction, into interstate commerce new
`
`drugs, as defined by 21 U.S.C. § 321(p), that are neither approved pursuant to 21 U.S.C.
`
`§ 355 nor exempt from approval;
`
`D.
`
`Violating 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 drug that are misbranded within the meaning of 21 U.S.C. § 352;
`
`E.
`
`Violating 21 U.S.C. § 331(k) by causing articles of drug to become
`
`misbranded within the meaning of 21 U.S.C. § 352, which such articles are held for sale
`
`after shipment of one or more of their components in interstate commerce; and
`
`F.
`
`Failing to implement and continuously maintain the requirements of this
`
`Decree.
`
`14.
`
`If, at any time after entry of this Decree, FDA determines, based on the results of
`
`an inspection, the analysis of a sample, a report, or data prepared or submitted by Defendants, the
`
`CGMP Expert, Labeling Expert, Auditor, or any other information, that Defendants have failed to
`
`comply with any provision of this Decree, Defendants have violated the Act or its implementing
`
`regulations, or additional corrective actions are necessary to achieve compliance with this Decree,
`
`
`
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`
`the Act, or its implementing regulations, FDA may, as and when it deems necessary, notify
`
`Defendants in writing of the noncompliance and order Defendants to take appropriate corrective
`
`action, including, but not limited to, ordering Defendants to immediately take one or more of the
`
`following actions:
`
`A.
`
`Cease receiving, manufacturing, preparing, packing, repacking, labeling,
`
`holding, or distributing any and all products;
`
`B.
`
`Recall, at Defendants’ expense, any product that in FDA’s judgment is
`
`adulterated, misbranded, or otherwise in violation of this Decree, the Act, or its
`
`implementing regulations;
`
`C.
`
`Revise, modify, expand, or continue to submit any reports, plans,
`
`procedures, or other records prepared pursuant to this Decree;
`
`D.
`
`E.
`
`F.
`
`G.
`
`Submit additional reports or information to FDA as requested;
`
`Institute or reimplement any of the requirements set forth in this Decree;
`
`Issue a safety alert; and/or
`
`Take any other corrective actions as FDA, in its discretion, deems necessary
`
`to protect the public health or bring Defendants into compliance with this Decree, the Act,
`
`or its implementing regulations. This remedy shall be separate and apart from, and in
`
`addition to, any other remedy available to the United States under this Decree or under the
`
`law.
`
`15.
`
`Upon receipt of any order issued by FDA pursuant to paragraph 14, Defendants
`
`shall immediately and fully comply with the terms of the order. Any cessation of operations or
`
`other action described in paragraph 14 shall continue until Defendants receive written notification
`
`from FDA that Defendants appear to be in compliance with this Decree, the Act, and its
`
`implementing regulations, and that Defendants may resume operations. Defendants shall pay all
`
`
`
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`costs of recalls and other corrective actions, including the costs of FDA’s inspections,
`
`investigations, supervision, analyses, examinations, sampling, testing, reviews, document
`
`preparation, travel, and subsistence expenses to implement and monitor the remedies set forth in
`
`paragraph 14, at the rates specified in paragraph 18.
`
`16.
`
`Representatives of FDA shall be permitted, without prior notice and as and when
`
`FDA deems necessary, to inspect Defendants’ operations and, without prior notice, take any other
`
`measures necessary to monitor and ensure continuing compliance with the terms of this Decree,
`
`the Act, and all applicable regulations. During such inspections, FDA representatives shall be
`
`permitted to: have immediate access to Defendants’ places of business including, but not limited
`
`to, all buildings, equipment, components, raw ingredients, in-process materials, finished products,
`
`containers, packaging material, labeling, and other material therein; take photographs and make
`
`video recordings; take samples, without charge to FDA, of Defendants’ components, raw
`
`ingredients, in-process materials, finished products, containers, packaging material, labeling,