CBD and Hemp General and Product Liability Application NameFirstLast Business Name: Business Address Street Address Street Address Line 2 City State / Province / Region Postal / Zip Code AfghanistanAlbaniaAlgeriaAndorraAngolaAntigua and BarbudaArgentinaArmeniaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelgiumBelizeBeninBhutanBoliviaBosnia and HerzegovinaBotswanaBrazilBruneiBulgariaBurkina FasoBurundiCambodiaCameroonCanadaCape VerdeCentral African RepublicChadChileChinaColombiaComorosCongoCongo (Brazzaville)Costa RicaCote d'IvoireCroatiaCubaCuracaoCyprusCzech RepublicDenmarkDjiboutiDominicaDominican RepublicEast Timor (Timor Timur)EcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEswatiniEthiopiaFijiFinlandFranceGabonGambia, TheGeorgiaGermanyGhanaGreeceGrenadaGuatemalaGuineaGuinea-BissauGuyanaHaitiHondurasHong KongHungaryIcelandIndiaIndonesiaIranIraqIrelandIsraelItalyJamaicaJapanJordanKazakhstanKenyaKiribatiKorea, NorthKorea, SouthKuwaitKyrgyzstanLaosLatviaLebanonLesothoLiberiaLibyaLiechtensteinLithuaniaLuxembourgMadagascarMalawiMalaysiaMaldivesMaliMaltaMarshall IslandsMauritaniaMauritiusMexicoMicronesiaMoldovaMonacoMongoliaMontenegroMoroccoMozambiqueMyanmarNamibiaNauruNepalNetherlandsNew ZealandNicaraguaNigerNigeriaNorth MacedoniaNorwayOmanPakistanPalauPalestinePanamaPapua New GuineaParaguayPeruPhilippinesPolandPortugalPuerto RicoQatarRomaniaRussiaRwandaSaint Kitts and NevisSaint LuciaSaint VincentSamoaSan MarinoSao Tome and PrincipeSaudi ArabiaSenegalSerbiaSeychellesSierra LeoneSingaporeSlovakiaSloveniaSolomon IslandsSomaliaSouth AfricaSouth SudanSpainSri LankaSudanSurinameSwedenSwitzerlandSyriaTaiwanTajikistanTanzaniaThailandTogoTongaTrinidad and TobagoTunisiaTurkeyTurkmenistanTuvaluUgandaUkraineUnited Arab EmiratesUnited KingdomUnited StatesUruguayUzbekistanVanuatuVatican CityVenezuelaVietnamWalesYemenZambiaZimbabwe Country Email Website Address: Type of EntityLLCCorporationPartnershipSole Proprietor Number of Years in Business Please describe your business and/or types of products/goods: Percentage of your gross sales generated by the following types of operations: Percentage of Gross SalesManufacturerContract ManufacturerWholesaler/DistributorImporterRetailer Own LabelRetailer-Products Sold of Other under Their LabelDirect to Customers Via InternetOther Projected Annual Revenue: Is 100% of your revenue derived from Hemp/CBD? YesNo Have you or will you use ingredients imported from foreign suppliers?NoYes If applicable, do you contract the manufacturing of your products to others? NoYes IF Wholesaler/Distributor selling products of others on theirlabel--Please list the manufacturers and addresses: Do your suppliers each provide you with a certificate of liability insurance? YesNo Do your suppliers also each provide you with additional insured-vendors certificate? YesNo If you are importer, please list the countries of origin: What is the percentage of such products formulated entirely by the customer? Percentage of overall sales that consist of products sold under the labels of your customers? Do you have written contract with each customer that includes hold harmless and indemnification agreements in your favor? YesNo Do you exclusively use ingredients supplied by your customer? YesNo Contract Packager: Do you have written contract with each customer that includes hold harmless and indemnification agreements in your favor? YesNo Do you have a written product recall procedure? YesNo Have you had to voluntarily or involuntarily recalled or withdrawn, or are you considering recalling or withdrawing any products for any reason? NoYes If applicable, are you fully compliant with FDA current good manufacturing practices? YesNo If applicable, are you compliant with FDCA-21 CFR 111 Act?YesNo Have you attained ISO 9000, as 9000 or similar registration or third party certification? YesNo Do you have a formal written OAP (or SOP) that is in full compliance with all applicable federal regulations and industry standards? YesNo Are all facilities used to manufacture, process, pack, hold or store your products registered with the FDA? YesNo If you are making or selling any Cannabinols/CBD products are they tested & certified by a 3rd party laboratory? YesNo CBd Products: Do you have documentation for each batch/lot? YesNo Are your products certified to contain no more than 0.3% THC and is it listed on the label? YesNo Has outside legal counsel reviewed your labeling and confirmed it is in compliance with theYesNo Do all of your labels include a disclaimer that the FDA has not evaluated the claims on your labels and that your products are not intended to diagnose, treat, cure or prevent any disease? YesNo Are you making any structure/function claims to substantiate your product claims? NoYes Have you or will you conduct human clinical trials to substantiate your product claims?NoYes In the past five years, have you submitted a Serious Adverse Event Report (SAER) to the FDA or has the FDA notified you of a Serious Adverse Event Report submitted directly by a health care provider, firm or consumer?NoYes Do you have a QAP/SOP detailing how to identify and handle on SA ER/SAE? YesNo Are you aware of any complaint or notice filed in the last three years with any governmental agency or industry regulatory body, including but not limited to the FDA or FTC, concerning your product?NoYes Have you been inspected by the FDA? NoYes Do you comply with Prop 65 labeling requirements?YesNo Would you like coverage for Hired and Non-Owned Auto? Example: Coverage when employees driver their vehicles for company business. YesNo Are you aware of any incident, condition, circumstance, lawsuit, legal action or suspected defect in any product or work, which may result in a demand for damages or claims against you that are not listed in the 5 year carrier loss history?NoYesSubmitReset
