Home Inspections, Compliance, Enforcement, and Criminal Investigations Compliance Actions and Activities Warning

Letters 2012
Inspections,Compliance,Enforcement,andCriminalInvestigations

HomeCareTechnologiesUSA,Inc.2/9/12

PublicHealthService
DepartmentofHealthandHumanServices
FoodandDrugAdministration
LosAngeles

PacificRegion

19701Fairchild

Irvine,CA926122506
Telephone:9496082900
FAX:9496084416
WARNINGLETTER
VIAUNITEDPARCELSERVICE
SIGNATUREREQUIRED
February9,2012

W/L1812

Mr.Qi(Philip)Zhu,OfficeManager
HomeCareTechnologiesUSA,Inc.
560WMainStC827

Alhambra,California918013374
DearMr.Zhu:
DuringaninspectionofyourfirmlocatedinAlhambra,California,onAugust15,2011,throughAugust18,2011,
aninvestigatorfromtheUnitedStatesFoodandDrugAdministration(FDA)determinedthatyourfirmimports
andrelabelsapoweredmusclestimulatordevice.Undersection201(h)oftheFederalFood,Drug,andCosmetic
Act(theAct),21U.S.C.321(h),thisproductisadevicebecauseitisintendedforuseinthediagnosisof
diseaseorotherconditionsorinthecure,mitigation,treatment,orpreventionofdisease,orisintendedtoaffect
thestructureorfunctionofthebody.
QualitySystemViolations
Thisinspectionrevealedthatthisdeviceisadulteratedwithinthemeaningofsection501(h)oftheAct(21U.S.C.
35l(h)),inthatthemethodsusedin,orthefacilitiesorcontrolsusedfor,itsmanufacture,packing,storage,or
installationarenotinconformitywiththecurrentgoodmanufacturingpracticerequirementsoftheQuality
SystemregulationfoundatTitle21,CodeofFederal.Regulations(CFR),Part820.Theseviolationsinclude,but
arenotlimitedto,thefollowing:
1.Failuretoestablishandmaintainprocedurestoensurethatallpurchasedorotherwisereceivedproduct
andservicesconformtospecifiedrequirements,asrequiredby21CFR820.50.
Forexample,yourfirmdoesnothaveanypurchasingcontrolsprocedurestoensurethatallpurchasedor
otherwisereceivedpoweredmusclestimulatordevicesconformtospecifiedrequirements.Yourfirmhasnot
evaluatedyoursupplierandvendorofthepoweredmusclestimulatordevice,yourlabelmanufacturer,or
youroverseasimportbrokerontheirabilitytomeetspecifiedrequirements,includingqualityrequirements.
2.Failuretoestablishandmaintainproceduresforreceiving,reviewing,andevaluatingcomplaintsbya
formallydesignatedunit,asrequiredby21CFR820.198(a).
Forexample,yourfirmdoesnothaveanycomplainthandlingproceduresforthepoweredmusclestimulator
device.
 3.FailuretomaintainDeviceMasterRecords(DMRs),asrequiredby21CFR820.181.
Forexample,yourfirmdoesnotmaintainaDMRforthepoweredmusclestimulatordevice.
Specifically,yourfirmdoesnothaveacompilationofrecordscontainingorreferringtothelocationofthe
informationregardingthedevicespecifications,productionprocessspecifications,qualityassurance
proceduresandspecifications,packagingandlabelingspecifications,andinstallation,maintenance,and
servicingproceduresandmethods.
4.FailuretoestablishandmaintainprocedurestoensurethatDeviceHistoryRecords(DHRs)foreach
batch,lot,orunitaremaintainedtodemonstratethatthedeviceismanufacturedinaccordancewiththe
DMRandtherequirementsof21CFRPart820,asrequiredby21CFR820.184.
Forexample,yourfirmdoesnothaveanyDHRproceduresforthepoweredmusclestimulatordevice.Your
firmdoesnothavedevicehistoryrecordsdocumentingtherelabelingofyourdevices,thequantitythat
wererelabeled,andexamplesofthelabelandlabelingused.
5.Failuretoestablishandmaintainprocedurestocontrollabelingactivities,asrequiredby21CFR820.120.
Forexample,yourfirmdoesnothaveanylabelingcontrolproceduresforthepoweredmusclestimulator
device.
MDRViolations
Ourinspectionalsorevealedthatyourfirm'sdeviceismisbrandedundersection502(t)(2)oftheAct,21U.S.C.
352(t)(2),inthatyourfirmfailedorrefusedtofurnishmaterialorinformationrespectingthedevicethatis
requiredbyorundersection519oftheAct,21U.S.C.360i,and21CFRPart803"MedicalDeviceReporting
(MDR).Significantviolationsinclude,butarenotlimitedto,thefollowing:
Failuretodevelop,maintain,andimplementwrittenMDRprocedures,asrequiredby21CFR803.17.
Forexample,yourfirmdoesnothaveanyMDRreportingprocedures.
UnapprovedDeviceViolations
Ourinspectionalsorevealedthatyourfirm'sdeviceisadulteratedunderSection501(f)(1)(B)oftheAct,21
U.S.C.351(f)(1)(B),becauseyourfirmdoesnothaveanapprovedapplicationforpremarketapproval(PMA)in
effectpursuanttoSection515(a)oftheAct,21U.S.C.360e(a),oranapprovedapplicationforaninvestigational
deviceexemption(IDE)underSection520(g)oftheAct,21U.S.C.360j(g).Yourfirm'sdeviceisalsomisbranded
underSection502(o)oftheAct,21U.S.C.352(o),becauseyourfirmdidnotnotifytheagencyofitsintentto
introducethedeviceintocommercialdistribution,asrequiredbySection510(k)oftheAct,21U.S.C.360(k).For
adevicerequiringpremarketapproval,thenotificationrequiredbysection510(k)oftheAct,21U.S.C.360(k),is
deemedsatisfiedwhenaPMAispendingbeforetheagency.[21CFR807.81(b)]Thekindofinformationthat
yourfirmneedstosubmitinordertoobtainapprovalorclearanceforthedeviceisdescribedontheInternetat
http://www.fda.gov/cdrh/devadvice/3122.html1.TheFDAwillevaluatetheinformationthatyourfirmsubmits
anddecidewhethertheproductmaybelegallymarketed.
Yourfirm'sdeviceisnotcoveredbyK023001becauseyourfirm'sdevicelabel,"GotPain?"brochure,anduser
manualforthedeviceincludeclaimsforthedevicethatwerenotclearedunderK023001andthatrepresenta
majorchangeormodificationintheintendeduseofthedeviceunder21CFR807.81(a)(3)(ii).Examplesofsuch
claimsinclude,butarenotlimitedto,thefollowing:
(a)ThepoweredmusclestimulatorwasclearedunderK023001withthefollowingindications:
Relaxationofmusclespasms;

Preventionorretardationofdisuseatrophy;
Musclereeducation;

Immediatepostsurgicalstimulationofcalfmusclestopreventvenousthrombosis;and
Maintainingorincreasingrangeofmotion.
However,yourfirm'srepackagedouterdevicelabel,"GotPain?''brochure,andusermanualcontainstatements
indicatingthatthepoweredmusclestimulatorsareindicatedforsportsinjuries,fibromyalgia,tensionandstress,
sinuscongestion,stiffneck,lowerbackpain,pinchednerves,bursitis,multiplesclerosis,osteoarthritis,phantom
limb)rheumatoidarthritis,diabeticneuropathy,clusterheadaches,dentaldisorders,migraineheadaches,
sprains/strains,generalheadaches,TemporomandibularJointsyndrome,anklepain,footpain,fractures,knee
pain,tendonitis,frozenshoulder,triggerfingers,carpaltunnel,tennis/golfelbow,wristpain,degenerativedisc
disease,bulgingdisc,herniations,sciaticpain,obesity,exerciseslimming,insomnia,menstruationpainand
irregularmenstruation,paraplegia,andmassage.TheseclaimsfalloutsideofthescopeofK023001and
constitutemajorchangesintheintendeduseofthedevice.
(b)Thedevice,asclearedunderK023001,isapoweredmusclestimulatornotaTranscutaneousElectrical
NerveStimulator(TENS).
However,theouterlabel,brochure,anduser'smanualforyourfirm'spoweredmusclestimulatorcontain
statementssuchas"ProfessionalQualityEMS/TENSHomeTherapyMassageUnit"and"EMS&TENSfrequencies."
TheseclaimsfalloutsideofthescopeofK023001andconstitutemajorchangesintheintendeduseofthedevice.
(c)Yourfirm'suser'smanualcontainsrecommendationsforplacementofthepoweredmusclestimulator
deviceonthechest,face,andothersuggestedplacementswhichcorrespondtotransthoracicuse,
transcerebraluse,useinproximitytothecarotidsinusnerves,anduseinproximitytotheneckormouth.
TheseclaimsfalloutsideofthescopeofK023001andconstitutemajorchangesintheintendeduseofthedevice.
(d)ThepoweredmusclestimulatorwasclearedunderK023001foruseunderthefollowingclinicalsetting:
"Thedeviceshouldonlybeusedundermedicalsupervisionforadjunctivetherapyforthetreatmentmedical
diseasesandconditions.''Thepoweredmusclestimulatorisforprescriptionuseonly.
However,yourfirm'srepackagedouterlabel,brochure,anduser'smanualforthepoweredmusclestimulatordo
notincludethestatement,"Caution:Federallawrestrictsthisdevicetosalebyorontheorderofapractitioner
licensedbythelawoftheStateinwhichhe/shepracticestouseorordertheuseofthedevice,"asrequiredto
identifythedevicesasprescriptionuseonlyinaccordancewith21CFR801.109.Achangefromprescriptionuse
onlytooverthecounteruseconstitutesamajorchangeintheintendeduseofthedevice.
Additionally,undersection510oftheAct(21U.S.C.360),manufacturersofmedicaldevicesarerequiredto
annuallyregisterwiththeFDA.InSeptember2007,section510oftheActwasamendedbytheFoodandDrug
AdministrationAmendmentsActof2007(Pub.L.11085)torequiredomesticandforeigndeviceestablishments
tosubmittheirannualestablishmentregistrationanddevicelistinginformationtoFDAbyelectronicmeans
[section510(p)oftheAct(21U.S.C.360(p))]duringtheperiodbeginningOctober1standendingDecember
31stofeachyear.Ourrecordsindicatethatyourfirmhasnotfulfilledannualregistrationandlistingrequirements
forfiscalyear2011,inthatyourfirmisnotproperlyregisteredasarepackager/relabelerandhasnotsubmitted
devicelistinginformation.
Thereforeyourfirm'sdeviceismisbrandedwithinthemeaningofsection502(o)oftheAct(21U.S.C.352(o)),
inthatthedevicewasmanufactured,prepared,propagated,compounded,orprocessedinanestablishmentnot
dulyregisteredundersection510oftheAct(21U.S.C.360)andwasnotincludedinalistrequiredbysection
510(j)oftheAct(21U.S.C.360(j)).
Yourfirmshouldtakepromptactiontocorrecttheviolationsaddressedinthisletter.Failuretopromptlycorrect
theseviolationsmayresultinregulatoryactionbeinginitiatedbytheFDAwithoutfurthernotice.Theseactions
include,butarenotlimitedto,seizure,injunction,andcivilmoneypenalties.Also,federalagenciesmaybe
advisedoftheissuanceofWarningLettersaboutdevicessothattheymaytakethisinformationintoaccount
whenconsideringtheawardofcontracts.Additionally,premarketapprovalapplicationsforClassIIIdevicesto
whichtheQualitySystemregulationviolationsarereasonablyrelatedwillnotbeapproveduntiltheviolations
havebeencorrected.RequestsforCertificatestoForeignGovernmentswillnotbegranteduntiltheviolations
relatedtothesubjectdeviceshavebeencorrected.
Pleasenotifythisofficeinwritingwithinfifteenbusinessdaysfromthedateyoureceivethisletterofthespecific
stepsyourfirmhastakentocorrectthenotedviolations,aswellasanexplanationofhowyourfirmplansto
preventtheseviolations,orsimilarviolations,fromoccurringagain.Includedocumentationofthecorrections
and/orcorrectiveactions(includinganysystemiccorrectiveactions)thatyourfirmhastaken.Ifyourfirm's
plannedcorrectionsand/orcorrectiveactionswilloccurovertime,pleaseincludeatimetableforimplementation
ofthoseactivities.Ifcorrectionsand/orcorrectiveactionscannotbecompletedwithinfifteenbusinessdays,state
thereasonforthedelayandthetimewithinwhichtheseactivitieswillbecompleted.Yourfirm'sresponseshould
becomprehensiveandaddressallviolationsincludedinthisWarningLetter.
Yourfirm'sresponseshouldbesentto:
BlakeBevill

Director,ComplianceBranch

FoodandDrugAdministration
19701Fairchild

Irvine,CA926122506
Ifyouhaveanyquestionsaboutthecontentsofthisletter,pleasecontact:Dr.RaymondW.Brullo,Compliance
Officerat9496082918.
Finally,youshouldknowthatthisletterisnotintendedtobeanallinclusivelistoftheviolationsatyourfirm's
facility.Itisyourfirm'sresponsibilitytoensurecompliancewithapplicablelawsandregulationsadministeredby
FDA.ThespecificviolationsnotedinthisletterandintheInspectionalObservations,FormFDA483,issuedatthe
closeoftheinspectionmaybesymptomaticofseriousproblemsinyourfirm'smanufacturingandquality
managementsystems.
Yourfirmshouldinvestigateanddeterminethecausesoftheviolations,andtakepromptactionstocorrectthe
violationsandbringtheproductsintocompliance.
Sincerely,
/s/
AlonzaE.Cruse,Director
LosAngelesDistrict

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