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`UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF ILLINOIS
`EASTERN DIVISION
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`UNITED STATES OF AMERICA,
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`Plaintiff,
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`v.
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`MORTON GROVE PHARMACEUTICALS,
`INC., a Delaware corporation, and
`GOPALAKRISHNAN VENKATESAN, an
`individual,
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`Defendants.
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`Case No. 22 C 4367
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`COMPLAINT FOR PERMANENT INJUNCTION
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`Plaintiff, the United States of America, by and through undersigned counsel, respectfully
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`represents as follows:
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`1. This statutory injunction proceeding is brought pursuant to the Federal Food, Drug,
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`and Cosmetic Act (“FDCA”), 21 U.S.C. § 332(a), to enjoin Morton Grove Pharmaceuticals, Inc.,
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`a Delaware corporation, and Gopalakrishnan Venkatesan, an individual (collectively,
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`“Defendants”), from: (a) violating 21 U.S.C. § 331(a) by introducing or delivering, or causing to
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`be introduced or delivered, into interstate commerce, drugs that are adulterated within the
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`meaning of 21 U.S.C. § 351(a)(2)(B); and (b) violating 21 U.S.C. § 331(k) by causing articles of
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`drug to become adulterated within the meaning of 21 U.S.C. § 351(a)(2)(B), while held for sale
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`after shipment of the drugs or one or more of their components in interstate commerce.
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`Jurisdiction and Venue
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`2.
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`Congress conferred upon district courts the authority to restrain such violations in
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`21 U.S.C. § 332(a). The court also has jurisdiction over this action pursuant to
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`28 U.S.C. §§ 1331, 1337, and 1345.
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`3.
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`Venue in this district is proper under 28 U.S.C. §§ 1391(b) and (c).
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`Defendants and their Operations
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`4.
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`Defendant Morton Grove Pharmaceuticals, Inc. (“MGP”) is a Delaware
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`corporation incorporated in 1995. Since 2007, MGP has been a majority owned subsidiary of
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`Wockhardt Limited. MGP’s principal place of business is 6451 Main St, Morton Grove, IL
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`60053-2633, which is within the jurisdiction of this Court. MGP manufactures non-sterile
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`prescription and over-the-counter finished drug products in the form of oral, topical, and nasal
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`solutions, suspensions, and powders (collectively, MGP’s “drug products”) and distributes them
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`to pharmaceutical wholesale distributors and large pharmacy chains.
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`5.
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`Defendant Gopalakrishnan Venkatesan is the president of, and the most
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`responsible person at, MGP.
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`Distribution of Drugs in Interstate Commerce
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`6.
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`Defendants are engaged at 6451 Main St, Morton Grove, IL 60053-2633, in
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`manufacturing, processing, packing, holding, and distributing a variety of products, including but
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`not limited to Fluticasone Propionate Nasal Spray, Promethazine Syrup Plain, and Promethazine
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`with Dextromethorphan Cough Syrup. All of MGP’s drug products are articles of drug, within
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`the meaning of 21 U.S.C. § 321(g)(1).
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`7.
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`Defendants manufacture MGP’s drug products using one or more components
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`shipped in interstate commerce from places outside the State of Illinois, including, for example,
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`Promethazine Hydrochloride, USP, which was shipped from Georgia, and liquid sugar, which
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`was shipped from Indiana.
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`8.
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`Defendants hold for sale MGP’s drug products and ship them to places outside the
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`state of Illinois, including for example, Promethazine with Codeine Oral Solution, which was
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`shipped to Kentucky.
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`Defendants’ Violations of the Act
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`9.
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`The FDCA requires drug manufacturers to operate in compliance with current
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`good manufacturing practice for drugs (“CGMP”). 21 U.S.C. § 351(a)(2)(B). The FDCA and
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`FDA’s CGMP regulations, 21 C.F.R. pts. 210 & 211, mandate that manufacturers control the
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`processes and procedures by which drugs are manufactured, processed, packed, and held in order
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`to ensure that drugs have the identity, strength, quality, purity, and other attributes necessary for
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`their safe and effective use. Drugs not made in conformance with CGMP are deemed to be
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`adulterated as a matter of law, regardless of whether they are deficient in any respect.
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`21 U.S.C. § 351(a)(2)(b); 21 C.F.R. § 210.1(b).
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`10.
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`Five FDA inspections of MGP during the period starting December 6, 2010 and
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`ending May 5, 2021 establish that the drugs that Defendants manufacture and distribute are
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`adulterated within the meaning of 21 U.S.C. § 351(a)(2)(B), because the methods used in, and
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`the facilities and controls used for, their manufacture, processing, packing, and holding are not in
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`compliance with CGMP. 21 C.F.R. pts. 210 & 211.
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`11.
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`FDA investigators most recently inspected MGP’s facility in Morton Grove,
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`Illinois, from April 19-May 20, 2021. During that inspection, FDA investigators documented
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`many deviations from CGMP. At the close of the inspection, FDA investigators issued a list of
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`inspectional observations (“Form FDA 483”) to Defendant MGP. The CGMP violations
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`observed during the inspection included, but were not limited to, the following:
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`A.
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`Failure to thoroughly investigate any unexplained discrepancy or failure of
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`a batch or any of its components to meet any of its specifications, whether or not the batch has
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`already been distributed, as required by 21 C.F.R. § 211.192, including the failure to reject drug
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`lots after discovering the use of a contaminated component and the failure to fully investigate the
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`root cause of the contamination;
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`B.
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`Failure to establish laboratory controls that include scientifically sound
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`and appropriate specifications, standards, sampling plans, and test procedures designed to assure
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`that components, drug product containers, closures, in-process materials, labeling, and drug
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`products conform to appropriate standards of identity, strength, quality, and purity, as required
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`by 21 C.F.R. § 211.160(b);
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`C.
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`Failure to clean, maintain, and, as appropriate for the nature of the drug,
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`sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions
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`or contamination that would alter the safety, identity, strength, quality, or purity of the drug
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`product beyond the official or other established requirements, as required by
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`21 C.F.R. § 211.67(a); and
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`D.
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`Failure to establish and follow laboratory control mechanisms, as required
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`by 21 C.F.R. § 211.160(a).
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`12.
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`In a letter to FDA dated June 12, 2021, an MGP official represented that MGP
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`was taking actions to correct the CGMP violations that the FDA investigators identified during
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`their 2021 inspection. FDA reviewed the letter and determined that many of the firm’s proposed
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`corrective actions are not adequate to fully address the CGMP violations that the FDA
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`investigators observed during their inspection.
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`13. MGP violates 21 U.S.C. § 331(a) by introducing or delivering for introduction
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`into interstate commerce its drug products, which are articles of drug, as defined by
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`21 U.S.C. § 321(g)(1), that are adulterated within the meaning of 21 U.S.C. § 351(a)(2)(B) in
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`that they have been manufactured, processed, packed, or held in violation of CGMP, 21 C.F.R.
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`parts 210 and 211.
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`14. MGP violates 21 U.S.C. § 331(k) by causing the adulteration of its drug products
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`within the meaning of 21 U.S.C. § 351(a)(2)(B), while they are held for sale after shipment of
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`one or more of their components in interstate commerce.
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`History of Noncompliance
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`15. MGP has a long history of violating the FDCA. Several of the CGMP deviations
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`observed during the most recent inspection (referenced in ¶ 11 above) are similar to those that
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`FDA investigators observed during prior inspections of MGP in August-October 2019, January-
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`February 2016, January-March 2014, and December 2010-April 2011.
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`16.
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`FDA’s inspections, and the repeat violations observed, demonstrate MGP’s
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`unwillingness or inability to comply with the law. For example, FDA documented MGP’s
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`failure to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its
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`components to meet any of its specifications (similar to the violation described in ¶ 11(A) above)
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`on at least four earlier occasions; MGP’s failure to establish adequate laboratory controls (similar
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`to ¶ 11(B) above) on at least two previous occasions; MGP’s failure to appropriately clean
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`equipment and utensils (similar to ¶ 11(C) above) on one prior occasion, in 2019, when FDA
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`investigators observed residue, chipped paint, and rust on equipment, and considering that MGP
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`uses the same equipment to manufacture different types of products but does not have processes
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`to ensure against product cross-contamination; and MGP’s failure to establish and follow
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`laboratory control mechanisms (similar to ¶ 11(D) above) on one prior occasion. FDA
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`inspectors documented numerous other CGMP violations at MGP during at least two FDA
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`inspections.
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`17. MGP’s noncompliance has continued despite repeated warnings from FDA. At
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`the close of each of the five inspections of MGP that FDA conducted during the period starting
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`December 6, 2010 and ending May 5, 2021, FDA investigators issued a detailed list of
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`Inspectional Observations (“Form FDA-483”) to the most responsible person at MGP, in which
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`the FDA investigators detailed the deficiencies that they observed during their inspections. In
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`each case, MGP responded to FDA either orally or in writing with promises to correct at least
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`some of the CGMP violations. Although MGP made some corrections in response to FDA’s
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`inspectional observations, it either failed to correct others or failed to sustain the corrections it
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`made, as shown by the FDA Investigators’ observations and documentation of ongoing, serious
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`CGMP violations on each successive inspection of MGP’s facility.
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`18.
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`FDA issued a warning letter to MGP in 2017, in which it described violations of
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`the CGMP that FDA investigators observed during FDA’s inspection of MGP during the period
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`starting January 4 and ending February 5, 2016. In the Warning Letter, FDA emphasized the
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`serious nature of the violations and alerted MGP that further regulatory action may result if MGP
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`did not correct the deficiencies.
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`19.
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`FDA held a regulatory meeting with MGP on November 20, 2014 to discuss the
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`CGMP violations that FDA investigators observed during their January-March 2014 inspection
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`of MGP. During this meeting, FDA stressed the importance of complying with all CGMP
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`requirements and warned that if the violations were not corrected, FDA may pursue enforcement
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`action.
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`20.
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`Based on the foregoing, Plaintiff believes that Defendants will continue to violate
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`the Act in the manner set forth above, unless the Court restrains them.
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`WHEREFORE, Plaintiff respectfully requests that the Court:
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`I.
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`Permanently restrain and enjoin, under 21 U.S.C. § 332(a), Defendants MGP
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`Venkatasan, and each of their officers, agents, representatives, employees, attorneys, and all
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`persons in active concert or participation with any of them, from directly or indirectly doing any
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`of the following acts:
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`a. Violating 21 U.S.C. § 331(a), by introducing or delivering, or causing to be introduced
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`or delivered, into interstate commerce drugs that are adulterated within the meaning of
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`21 U.S.C. § 351(a)(2)(B); and
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`b. Violating 21 U.S.C. § 331(k), by causing drugs that Defendants hold for sale after
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`shipment of one or more of their components in interstate commerce to become adulterated
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`within the meaning of 21 U.S.C. § 351(a)(2)(B).
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`II.
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`Permanently restrain and enjoin, under 21 U.S.C. § 332(a), Defendants, and each
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`and all of their directors, officers, agents, representatives, employees, attorneys, successors, and
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`assigns, and any and all persons in active concert or participation with any of them, from
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`manufacturing, processing, packing, labeling, holding, or distributing drugs from MGP, unless
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`and until Defendants’ methods, facilities, and controls used to manufacture, process, pack, label,
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`and hold drugs are established, operated, and administered in conformity with CGMP and the
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`Act, in a manner that FDA finds acceptable.
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`III.
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`Authorize FDA to inspect Defendants’ places of business and all records relating
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`to the receipt, manufacture, processing, packing, labeling, holding, and distribution of any drug
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`or drug component, to ensure continuing compliance with the terms of the injunction, with the
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`costs of such inspections to be borne by Defendants at the rates prevailing at the time the
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`inspections are accomplished; and
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`IV.
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`Award Plaintiff costs and other such relief as the court deems just and proper,
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`including equitable monetary relief.
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`BRIAN M. BOYNTON
`Principal Deputy Assistant Attorney General
`Civil Division
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`ARUN G. RAO
`Deputy Assistant Attorney General
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`GUSTAV W. EYLER
`Director
`Consumer Protection Branch
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`ALLAN GORDUS
`Assistant Director
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`/s/________________________________
`CHRISTINA PARASCANDOLA
`Senior Litigation Counsel
`Consumer Protection Branch
`Department of Justice
`P.O. Box 386
`Washington, D.C. 20044
`(202) 514-3097
`christina.parascandola@usdoj.gov
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`Respectfully submitted,
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`JOHN R. LAUSCH, JR.
`United States Attorney
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`/s/________________________________
`Donald R. Lorenzen
`DONALD LORENZEN
`Senior Litigation Counsel
`Consumer Protection Branch
`Special Assistant United States Attorney
`219 S. Dearborn St., 5th Floor
`Chicago, IL 60604
`(312) 353-5330
`donald.lorenzen@usdoj.gov
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`OF COUNSEL:
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`MARK RAZA
`Chief Counsel
`Food and Drug Administration
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`PERHAM GORJI
`Deputy Chief Counsel for Litigation
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`JOSHUA A. DAVENPORT
`Associate Chief Counsel for Enforcement
`United States Department of Health and
` Human Services
`Office of the General Counsel
`White Oak 31, Room 4426A
`10903 New Hampshire Avenue
`Silver Spring, MD 20993-0002
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