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Consent Decree_USA v. McNeil PPC-2ndSave

Consent Decree_USA v. McNeil PPC-2ndSave

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Published by roslyn rudolph

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Categories:Types, Business/Law
Published by: roslyn rudolph on Oct 21, 2011
Copyright:Attribution Non-commercial

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10/07/2013

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INTHEUNITEDSTATESDISTRICT
cormr
FORTHEEASTERNDISTRICTOFPENNSYLVANIA
1.74
UNITEDSTATESOFAMERICA,Plaintiff,
Civil
~ctionNo.
---
v.MCNEIL-PPC,INC.,
a
corporation,andVERONICACRUZandHAKANERDEMIR,individuals,Defendants.
ATRUECo~y~~STIEIEOJ139MT,HE
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DATED:
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CONSENTDECREEOFPERMANENTINJUNCTIONPlaintiff,theUnitedStatesofAmerica,byitsundersignedattorneys,havingfiledaComplaintforPermanentInjunction("Complaint")againstMcNErL-PPC,Inc.,aNewJerseyCorporationdoingbusinessinPennsylvania,andelsewhere("McNEIL-ppe");VeronicaCruz,VicePresidentofQuality,McNeilConsumerHealthcareDivisionofMcNEIL-PPC,Inc.,FortWashington,Pennsylvania;andHakanErdemir,VicePresidentofOperations,Over-the-CounterProducts,McNeilConsumerHealthcareDivisionofMcNEIL-PPC,Inc.(hereafter,collectively,"Defendants"),andDefendantshavingappearedandconsentedtoentryofthisConsentDecreeofPermanentInjunction("Decree")withoutcontest,withoutadmittingordenyingtheallegations
in
theComplaint,anddisclaiminganyliabilityinconnectionherewith,andbeforeanytestimonyhasbeentaken,andtheUnitedStatesofAmerica,havingconsentedtothisDecree;VeronicaCruz,anIndividualDefendant,andMcNEIL-PPC,havingrepresentedthatCruzassumedherpositionasVicePresidentofQualityfortheMcNeilConsumerHealthcareDivisionofMcNElL-PPC,Inc.,onFebruary15,2010,tohelpimprovethequalitysystemsandoperations
 
oftheOver-the-CounterbusinessunitandresolveissuesraisedbytheUnitedStatesFoodandDrugAdministration("FDA");andHakanErdemir,anIndividualDefendant,andMcNElL-PPC,havingrepresentedthatErdemirassumedthepositionofVicePresidentofNorthAmericaOperations,Over-the-CounterProducts,fortheMcNeilConsumerHealthcareDivisionofMcNEIL-PPC,Inc.onMay3,2010,tohelpimprovethequalitysystemsandoperationsoftheOver-the-CounterbusinessunitandresolveissuesraisedbyFDA;ITISHEREBYORDERED,ADJUDGED,ANDDECREEDthat:1.ThisCourthasjurisdictionoverthesubjectmatterofthisactionandhaspersonaljurisdictionoverallpartiestothisactionpursuantto21U.S.C.§332(a)and28U.S.C.§1345.2.VenueisproperinthisDistrictunder28U.S.C.
§§
1391(b)and(c)..3.TheComplaintallegesacauseofactionagainstDefendantsundertheFederalFood,Drug,andCosmeticAct,21U.S.C.
§§
301-397(''theAct"),asfollows:A.TheUnitedStatesallegesthattheDefendantsviolate21U.S.C.
§
331(a),byintroducingandcausingtobeintroduced,anddeliveringandcausingtobedeliveredforintroductionintointerstatecommercearticlesofdrug,asdefinedby21U.S.C.
§
321(g)(l)(hereinafter,"drug"or"drugs"),thatareadulteratedwithinthemeaningof21U.S.C.
§
351(a)(2)(8),inthattheyhavebeenmanufactured,processed,packed,labeled,held,anddistributedinviolationofCurrentGoodManufacturingPractice("CGMP',)requirements,21U.S.C.
§
351(a)(2)(B)and21C.F.R.Parts210and211;andB.TheUnitedStatesallegesthattheDefendantsviolate21U.S.C.
§
331(k),bycausingtheadulterationwithinthemeaningof21U.S.C.§351(a)(2)(B)ofarticlesofdrugaftershipmentofoneormoreoftheircomponentsininterstatecommerce.2
 
4.ForthepurposesofthisDecree,"days"shallrefertocalendardaysunlessotherwisestated.
If
anydeadlineunderthisDecreefallsonaweekendorfederalholiday,thedeadlineiscontinuedtothenextbusinessday.5.Withinthirty(30)daysofentryofthisDecree,DefendantsshallprovidetoFDAaschedulefordestructionofalllotsofdrugsinMcNEIL-PPC'spossession,custody,andlorcontrolthatweremanufacturedatitsfacilityinFortWashington,Pennsylvania(the"FortWashingtonFacility"),orthefacilitiesitoperatesinLasPiedras,PuertoRico(the"LasPiedrasFacility")andLancaster,Pennsylvania(the"LancasterFacility"),andwererecalledbyMcNEIL-PPCfromDecember2009throughthedateofentryofthisDecree.WithrespecttoanyadditionalrecalleddrugsmanufacturedattheFortWashington,LasPiedrasorLancasterFacilitiesthatsubsequentlycomeintoMcNEIL-PPC'spossession,custody,andlorcontrolafterentryofthisDecree,Defendantsshallquarantineanysuchproducts,notifyrepresentativesoftheUnitedStatesFoodandDrugAdministration(''FDA'')(nolessfrequentlythanquarterly)inwritingofreceiptofsuchdrugs,anddestroyallsuchproductsnolaterthanninety(90)daysaftertheirreceipt.DefendantsshallprovideFDAten(10)daysadvancewrittennoticeofanydestructiontobeperformedunderthisParagraphtoaffordFDAanopportunitytosupervisethedestruction.IfFDArepresentativessupervisethedestruction,McNEIL-PPCshallreimburseFDAforallcostsassociatedwithsuchsupervisionwithinthirty(30)daysofreceivingabillofcostsfromFDA.IfFDAchoosesnottowitnessthedestruction,DefendantsshallprovideFDAwithadetailedwritteninventoryoftheproductsdestroyedandthemanneroftheirdestructionwithinfive(5)businessdaysofsuchdestruction.Defendantsshallnotdisposeofanydrugsinamannercontrarytoanyfederal,state,orlocallaws,includingbutnotlimitedto,theNationalEnvironmentalPolicyActof1969.
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