美国FDA第三方物流(3PL)供应商/医药批发零售商(WDD)报告 美国FDA第三方物流(3PL)供应商/医药批发零售商(WDD)报告 美国FDA要求第三方物流供应商以及医疗批发零售商要在每年的1月1日至3月31日之间为其名下所有企业报告其执照状态及其他的信息。除其他相关因素外,报告必须要包含州政府或者联邦政府在过去一年中对该企业采取的所有处罚。 您只需将如下表格填写完整,即可获得第三方物流(3PL)供应商/医药批发零售商(WDD)报告方面的协助: This field is hidden when viewing the formSend Incomplete sendIncomplete This field is hidden when viewing the formGCLIDThis field is hidden when viewing the formLanding PageThis field is hidden when viewing the formInternational Office EmailThis field is hidden when viewing the formForm TypedefaultshortdetailedThis field is hidden when viewing the formDownload TypeHARPC vs HACCP10 Things to Know for US Food ImportersThis field is hidden when viewing the formInquiry Type*3PL/WDD ReportingAdverse Event ContactAssessment ofAutomated ComplianceCalifornia ReportingCertificate of RegistrationColor AdditiveContent DownloadDetention AssistanceDUNS Assistance for VoortmanDrug ListingseMDREmergency Use AuthorizationExport ListingExport CertificatesFCE-SIDFDA Compliance MonitorFDA Compliance Monitor TrialHARPC Food Safety PlanFacility 360 TrialFood Contact SubstancesFood Defense PlanFood Safety Plan / PCQI Course BundleFSVPFSVP AgentGlobal RegulationHACCP PlanHealth Canada LicenseImport Alert CheckerKosher CertificationLabel ReviewMarketplaceMaster FilesMaster Manufacturing RecordsMonitor EnterpriseOMUFA ArrearsOutsourcing FacilityPartnership ProgramPrescription Drug SerializationOutbound ReferralREDRegiScoreSeafood and Juice Importer VerificationSelf-IdentificationShell Egg RegistrationSID VerificationUDI and GUDIDVerify RegistrationTestWaiting ListWebinarThis field is hidden when viewing the formIndustryFood and BeverageDietary SupplementsMedical DevicesDrugsCosmeticsTobaccoREDBiologicsThis field is hidden when viewing the formLead SourceThis field is hidden when viewing the formLead CategoryThis field is hidden when viewing the formCampaign SourceThis field is hidden when viewing the formCampaign TermThis field is hidden when viewing the formCampaign MediumThis field is hidden when viewing the formCampaign NameThis field is hidden when viewing the formCampaign ContentThis field is hidden when viewing the formMatch Type我司进口* 果汁 果汁 Detention Options 我需要美国FDA扣货的协助。 我需要美国FDA有关进口警报的协助。 I would like to export toAfghanistanAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelgiumBelizeBeninBermudaBhutanBoliviaBonaire, Sint Eustatius and SabaBosnia and HerzegovinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBrunei DarrussalamBulgariaBurkina FasoBurundiCambodiaCameroonCanadaCape VerdeCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos IslandsColombiaComorosCongo, Democratic Republic of theCongo, Republic of theCook IslandsCosta RicaCroatiaCubaCuraçaoCyprusCzech RepublicCôte d'IvoireDenmarkDjiboutiDominicaDominican RepublicEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEswatini (Swaziland)EthiopiaFalkland IslandsFaroe IslandsFijiFinlandFranceFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuamGuatemalaGuernseyGuineaGuinea-BissauGuyanaHaitiHeard and McDonald IslandsHoly SeeHondurasHong KongHungaryIcelandIndiaIndonesiaIranIraqIrelandIsle of ManIsraelItalyJamaicaJapanJerseyJordanKazakhstanKenyaKiribatiKuwaitKyrgyzstanLao People's Democratic RepublicLatviaLebanonLesothoLiberiaLibyaLiechtensteinLithuaniaLuxembourgMacauMacedoniaMadagascarMalawiMalaysiaMaldivesMaliMaltaMarshall IslandsMartiniqueMauritaniaMauritiusMayotteMexicoMicronesiaMoldovaMonacoMongoliaMontenegroMontserratMoroccoMozambiqueMyanmarNamibiaNauruNepalNetherlandsNew CaledoniaNew ZealandNicaraguaNigerNigeriaNiueNorfolk IslandNorth KoreaNorthern Mariana IslandsNorwayOmanPakistanPalauPalestine, State ofPanamaPapua New GuineaParaguayPeruPhilippinesPitcairnPolandPortugalPuerto RicoQatarRomaniaRussiaRwandaRéunionSaint BarthélemySaint HelenaSaint Kitts and NevisSaint LuciaSaint MartinSaint Pierre and MiquelonSaint Vincent and the GrenadinesSamoaSan MarinoSao Tome and PrincipeSaudi ArabiaSenegalSerbiaSeychellesSierra LeoneSingaporeSint MaartenSlovakiaSloveniaSolomon IslandsSomaliaSouth AfricaSouth GeorgiaSouth KoreaSouth SudanSpainSri LankaSudanSurinameSvalbard and Jan Mayen IslandsSwedenSwitzerlandSyriaTaiwanTajikistanTanzaniaThailandTimor-LesteTogoTokelauTongaTrinidad and TobagoTunisiaTurkeyTurkmenistanTurks and Caicos IslandsTuvaluUS Minor Outlying IslandsUgandaUkraineUnited Arab EmiratesUnited KingdomUnited StatesUruguayUzbekistanVanuatuVenezuelaVietnamVirgin Islands, BritishVirgin Islands, U.S.Wallis and FutunaWestern SaharaYemenZambiaZimbabweÅland IslandsI would like assistance with 食品和饮料 膳食补充剂 医疗器械 药品 化妆品 This field is hidden when viewing the formI would like assistance with Registration Agent Located in Region Labeling Requirements Good Manufacturing Practices Safety Plans Color Additives Adverse Event Reporting Master Files 其它 Specify Other*This field is hidden when viewing the formRegulations Summary你需要在什么类型的主文件上得到帮助?药物主文件医疗器械主文件 (MAF)兽药主文件您需要向什么国家/地区提交主文件?United States (U.S. FDA)Canada (Health Canada)China (NMPA)Australia (TGA)BahrainBosnia and HerzegovinaEuropean UnionHungaryJordanKuwaitOmanQatarSaudi ArabiaSouth AfricaThailandUnited Arab EmiratesUnited Kingdom (MHRA)提供贵司信息This field is hidden when viewing the formAssessment Type Label Assessment Food Safety Plan Assessment Post BTA This field is hidden when viewing the formFile to assess Food Safety Plan Product Labels 贵司的食品安全计划符合FDA的要求吗? 美国FDA要求大多数类型的已注册食品企业建立危害分析和基于风险的预防控制(HARPC)计划。HARPC计划必须遵循美国FDA规定的特定标准。其他食品安全体系可能不能完全满足FDA的要求。 U.S. FDA requires most types of registered food facilities to implement Hazard Analysis and Risk-Based Preventive Controls (HARPC) Plans. A HARPC plan must follow unique standards mandated by U.S. FDA. Other food safety systems may not completely satisfy FDA requirements.FDA新标签规定的最后期限即将到来 许多食品公司只有不到XX个月的时间来更新他们的标签,以符合新的FDA标签规则。新规定包括更新营养成分表、食用分量、强制声明等。出口美国的货物有超过22%的扣货是由于贴标错误导致的。 在货物被FDA扣留之前,很多企业都不知道他们的产品标签是不符合FDA的要求的。贴标错误兼有可能导致货物被延期,需要重新贴标或者销毁。让Registrar Corp的专家审核贵司的产品标签是否符合FDA的要求可以避免货物到港时因标签不合规导致的高额损失。上传贵司当前的食品安全计划进行免费评估 Drop files here or Select files Max. file size: 50 MB. 上传贵司的产品标签进行免费的初步评估 Drop files here or Select files Max. file size: 50 MB. 您有贵司的注册号和PIN吗?* 是 否 您有贵司的FURLS用户名和密码吗?* 是 否 注意: 若没有如下信息Registrar Corp将无法核实贵司的注册状态: 注册号码,以及PIN码;或登录FDA系统的用户名和密码。若贵司均不知道上述信息,最好立即注册新的号码。立即重新注册Routing Number*国家*选择您的国家AfghanistanAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelgiumBelizeBeninBermudaBhutanBoliviaBonaire, Sint Eustatius and SabaBosnia and HerzegovinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBrunei DarrussalamBulgariaBurkina FasoBurundiCambodiaCameroonCanadaCape VerdeCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos IslandsColombiaComorosCongo, Democratic Republic of theCongo, Republic of theCook IslandsCosta RicaCroatiaCubaCuraçaoCyprusCzech RepublicCôte d'IvoireDenmarkDjiboutiDominicaDominican RepublicEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEswatini (Swaziland)EthiopiaFalkland IslandsFaroe IslandsFijiFinlandFranceFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuamGuatemalaGuernseyGuineaGuinea-BissauGuyanaHaitiHeard and McDonald IslandsHoly SeeHondurasHong KongHungaryIcelandIndiaIndonesiaIranIraqIrelandIsle of ManIsraelItalyJamaicaJapanJerseyJordanKazakhstanKenyaKiribatiKuwaitKyrgyzstanLao People's Democratic RepublicLatviaLebanonLesothoLiberiaLibyaLiechtensteinLithuaniaLuxembourgMacauMacedoniaMadagascarMalawiMalaysiaMaldivesMaliMaltaMarshall IslandsMartiniqueMauritaniaMauritiusMayotteMexicoMicronesiaMoldovaMonacoMongoliaMontenegroMontserratMoroccoMozambiqueMyanmarNamibiaNauruNepalNetherlandsNew CaledoniaNew ZealandNicaraguaNigerNigeriaNiueNorfolk IslandNorth KoreaNorthern Mariana IslandsNorwayOmanPakistanPalauPanamaPapua New GuineaParaguayPeruPhilippinesPitcairnPolandPortugalPuerto RicoQatarRomaniaRussiaRwandaRéunionSaint BarthélemySaint HelenaSaint Kitts and NevisSaint LuciaSaint MartinSaint Pierre and MiquelonSaint Vincent and the GrenadinesSamoaSan MarinoSao Tome and PrincipeSaudi ArabiaSenegalSerbiaSeychellesSierra LeoneSingaporeSint MaartenSlovakiaSloveniaSolomon IslandsSomaliaSouth AfricaSouth GeorgiaSouth KoreaSouth SudanSpainSri LankaSudanSurinameSvalbard and Jan Mayen IslandsSwedenSwitzerlandSyriaTaiwanTajikistanTanzaniaThailandTimor-LesteTogoTokelauTongaTrinidad and TobagoTunisiaTurkeyTurkmenistanTurks and Caicos IslandsTuvaluUS Minor Outlying IslandsUgandaUkraineUnited Arab EmiratesUnited KingdomUnited StatesUruguayUzbekistanVanuatuVenezuelaVietnamVirgin Islands, BritishVirgin Islands, U.S.Wallis and FutunaWest BankWestern SaharaYemenZambiaZimbabweÅland Islands公司名称*联系人姓名*电子邮箱* 电话*实际地址*城市*州/省/区域邮政编码Is your company headquartered in the United States?*Please SelectYesNoApproximate Number of SuppliersPlease Select1-56-2526-5051-100More than 100I Need Assistance With: Regulatory Updates via Email New FDA Food Facility Registration Renew FDA Food Facility Registration U.S. Agent Service for FDA Communications Facility 360 FDA Prior Notice Labeling and Ingredient Review FCE-SID Regulations Preparing for FDA Inspection HACCP or HARPC Food Safety Plan Food Defense Plan Foreign Supplier Verification Program (FSVP) Detention/DWPE Assistance FDA Compliance Monitor Other I Need Assistance With: Regulatory Updates via Email 药品企业注册费 Drug Listings New Blanket No-Change Certification U.S. Agent and Registrant Contact Self-Identification for Generic Drugs Drug Labeling and Ingredient Requirements Drug Master Files eCTD Requirements Detention/DWPE Assistance FDA Compliance Monitor 其它 I Need Assistance With: Regulatory Updates via Email Cosmetic Labeling and Ingredient Requirements California Safe Cosmetics Reporting Voluntary Cosmetic Registration Program (VCRP) Color Additives / Color Batch Certification Detention/Import Alert Assistance 其它 I Need Assistance With: Regulatory Updates via Email Medical Device Establishment Registration U.S. Agent and/or Official Correspondent 医疗器械产品列名 Unique Device Identifier (UDI) Requirements Device Labeling Requirements Electronic Medical Device Reporting (eMDR) Medical Device Master Files (MAF) Detention/Import Alert Assistance 其它 其它*Website建议或意见This field is hidden when viewing the formRegistration StatusFDA注册号*(11位数号码)FDA身份识别码 (PIN)*(大写字母请指出。) FURLS用户名*FURLS密码*FDA医疗器械所有者/经营者号码邓白氏编码企业设施编码 (FEI)Labeler CodeCompliance InformationFDA注册号FDA身份识别码 (PIN)List Products You Would Like to Ship* Upload Labels for the Products Listed Above Drop files here or Select files Max. file size: 50 MB. Upload Food Safety Plan* Drop files here or Select files Max. file size: 50 MB. FCE注册号码*SID号码 (YYYYMMDD###)* 上传贵司的标签Max. file size: 15 MB. 上传贵司的食品安全计划Max. file size: 15 MB.Upload Your Product Label Drop files here or Select files Max. file size: 15 MB, Max. files: 10. 上传贵司的食品安全计划 Drop files here or Select files Max. file size: 15 MB. Upload Your HACCP Plan Drop files here or Select files Max. file size: 15 MB. 如果您目前已经扣货,请见FDA的扣货通知(NOA)发送给我们。 Drop files here or Select files Max. file size: 15 MB. 上传贵司的主生产记录 Drop files here or Select files Max. file size: 15 MB. I would like assistance with Export Listing Requirements Export Certificates Which Products Would You Like Help With? Dairy Exports to Chile, China, or the EU Collagen and Gelatin Exports to the EU Seafood Exports to the EU or China Infant Formula Exports to China 您需要哪类出口证书?* 致外国政府证书 - 食品和饮料 自由销售证书 致外国政府证书 - 医疗器械 医药产品证书 化妆品证书 Health Certificates - Collagen and Gelatin Exported to the EU 下方那个选项更符合贵司的产品?* 生产商拥有至少一个获得NIOSHNIOSH使用非常高的标准来测试和批准用于职业用途的口罩。通过NIOSH批准的一次性呼吸防护口罩上标有制造商名称、部件编号(P/N)、过滤等级(如N-95)和“NIOSH”字样。这些信息被印在面罩、呼气阀盖或头带上。批准的过滤式呼吸口罩,该呼吸器是根据其他国家适用的授权标准生产的 该产品获得了中国以外的其他国家监管机构的资质证书 该产品具有一份由受认可的独立实验室出具的检测报告,证明其产品符合特定的性能标准 该产品包含在美国疾控中心(CDC)发布的“新冠肺炎疫情期间N95口罩替代品清单”上 通过NIOSH认证的口罩*请为您的每一种获得NIOSH批准的防护口罩提供以下信息生产商名称型号NIOSH批准号 请提供有关贵司产品的以下信息生产商名称*生产商地址*城市*州/省/区域邮政编码国家*选择您的国家AfghanistanAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelgiumBelizeBeninBermudaBhutanBoliviaBonaire, Sint Eustatius and SabaBosnia and HerzegovinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBrunei DarussalamBulgariaBurkina FasoBurundiCambodiaCameroonCanadaCape VerdeCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos IslandsColombiaComorosCongo, Democratic Republic of theCongo, Republic of theCook IslandsCosta RicaCroatiaCubaCuraçaoCyprusCzech RepublicCôte d'IvoireDenmarkDjiboutiDominicaDominican RepublicEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEswatini (Swaziland)EthiopiaFalkland IslandsFaroe IslandsFijiFinlandFranceFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuamGuatemalaGuernseyGuineaGuinea-BissauGuyanaHaitiHeard and McDonald IslandsHoly SeeHondurasHong KongHungaryIcelandIndiaIndonesiaIranIraqIrelandIsle of ManIsraelItalyJamaicaJapanJerseyJordanKazakhstanKenyaKiribatiKuwaitKyrgyzstanLao People's Democratic RepublicLatviaLebanonLesothoLiberiaLibyaLiechtensteinLithuaniaLuxembourgMacauMacedoniaMadagascarMalawiMalaysiaMaldivesMaliMaltaMarshall IslandsMartiniqueMauritaniaMauritiusMayotteMexicoMicronesiaMoldovaMonacoMongoliaMontenegroMontserratMoroccoMozambiqueMyanmarNamibiaNauruNepalNetherlandsNew CaledoniaNew ZealandNicaraguaNigerNigeriaNiueNorfolk IslandNorth KoreaNorthern Mariana IslandsNorwayOmanPakistanPalauPanamaPapua New GuineaParaguayPeruPhilippinesPitcairnPolandPortugalPuerto RicoQatarRomaniaRussiaRwandaRéunionSaint BarthélemySaint HelenaSaint Kitts and NevisSaint LuciaSaint MartinSaint Pierre and MiquelonSaint Vincent and the GrenadinesSamoaSan MarinoSao Tome and PrincipeSaudi ArabiaSenegalSerbiaSeychellesSierra LeoneSingaporeSint MaartenSlovakiaSloveniaSolomon IslandsSomaliaSouth AfricaSouth GeorgiaSouth KoreaSouth SudanSpainSri LankaSudanSurinameSvalbard and Jan Mayen IslandsSwedenSwitzerlandSyriaTaiwanTajikistanTanzaniaThailandTimor-LesteTogoTokelauTongaTrinidad and TobagoTunisiaTurkeyTurkmenistanTurks and Caicos IslandsTuvaluUS Minor Outlying IslandsUgandaUkraineUnited Arab EmiratesUnited KingdomUnited StatesUruguayUzbekistanVanuatuVenezuelaVietnamVirgin Islands, BritishVirgin Islands, U.S.Wallis and FutunaWestern SaharaYemenZambiaZimbabweÅland Islands产品型号*贵司计划出口多少种口罩到美国? 上传贵司的标签 Drop files here or Select files Max. file size: 50 MB. 上传经营许可文件/证书文件/证书应由其他监管机构或者资质评定机构出具。(若有)请提供许可编号以及评定机构名称。 Drop files here or Select files Max. file size: 50 MB. 检测机构名称上传符合其他标准的证书 Drop files here or Select files Max. file size: 50 MB. 上传检测报告报告应证明产品已经达到相应的性能标准 Drop files here or Select files Max. file size: 50 MB. 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