Registro fda

REGISTRO ANTE LA FDA SERVICIO : $99.00

Toda empresa que se ingresen productos de consumo humano y/o animal a los Estados Unidos debe estar registrada ante la FDA (Administración de Alimentos y Medicamentos de los Estados Unidos), y contar con la representación de un Agente Residente.

Renovación del Registro ante la FDA

Los exportadores deben renovar su registro ante la FDA entre el 1 de octubre y el 31 de diciembre de 2020.

ITB HOLDINGS LLC como su Agente ante la FDA en los E.E.U.U.

■ Actuamos como enlace entre su empresa y la FDA, respondiendo a preguntas relacionadas con sus productos y ayudamos a la FDA y a usted a programar las inspecciones.

■ Hemos actuado como agente con la capacidad de representar ante la FDA de los Estados Unidos desde el año 2009.

■ Nuestra experiencia en la labor y apoyo en ese campo, les garantiza seriedad seguridad en los trámites de registro y actualización permanente de sus datos.

■ Ofrecemos una cuoto anual de 99 dólares EE.UU, iniciando el pago al momento del proceder con el registro de la empresa.

■ Oportunidades para propietarios y gerentes de startups, pequeñas y medianas empresas (PYME).

■ Soporte en vivo. Pregúntenos lo que quiera.

■ Obtenga una respuesta a su correo electrónico en 30 minutos.

■ ITB HOLDINGS LLC no es ni un representante comercial o un representante legal para los Estados Unidos.

DURACIÓN DEL TRÁMITE DE REGISTRO

■ Entre 48-72 horas a partir del pago por tarjeta

■ El mismo día por una tarifa adicional


COSTE DEL SERVICIO

99.00 Dólares

■ 72 horas a partir del pago por tarjeta

■ El mismo día: 198 dólares EE.UU

■ Empresas de alimentos y bebidas

■ Empresas de suplementos alimenticios


QUÉ INCLUYE ESTE SERVICIO

El registro ante la FDA. Tiene validez de 1 año

El servicio de agente ante la FDA. Tiene validez de 1 año

¿Quién debe registrarse?

Todas las instalaciones, nacionales e internacionales, que fabriquen, procesen, empaqueten o almacenen productos para consumo humano o animal en EEUU deben registrarse en la FDA.

Exportador, Importador

Fabricante de alimentos

Fabricante de alimentos para mascotas

Fabricante de suplementos alimenticios

Tienda, almacén

¿Qué tipo de alimentos están incluidos?

◇ Suplementos dietéticos e ingredientes dietéticos

◇ Formula para bebés (alimentos para bebés)

◇ Bebidas, inclusive bebidas alcohólicas y agua embotellada

◇ Frutas y vegetales

◇ Pescados y frutos de mar

◇ Productos lácteos y cáscara de huevo

◇ Productos agrícolas crudos para uso alimenticio o como componente alimenticio

◇ Alimentos enlatados o congelados

◇ Animales comestibles vivos

◇ Productos panificados, comida rápida, caramelos y goma de mascar

◇ Alimentos para animales y mascotas

¿CÓMO SOLICITAR EL NÚMERO DE REGISTRO FDA? | Empieza aquí

Es esencial que el cliente proporcione la siguiente información:

■ Nombre completo de la empresa que desea registrar

■ Dirección de la empresa

■ Número de buzón postal, número de teléfono, y dirección de correo electrónico de la empresa

■ Nombre, número de teléfono y dirección de correo electrónico del administrador de la empresa

■ Tipo de actividad a la que se dedica la empresa, si es productor, exportador o empaquetador

■ Qué tipo de producto van a exportar. La venta de queso en América está sujeta a reglamentaciones tanto de la FDA como de la USDA (Departamento de agricultura americano).


OTROS SERVICIOS

  • Fábricas de Conservas
  • Revisión de Etiquetas de Alimentos
  • Aviso Previo
  • Programa de Verificación de Proveedores Extranjeros (FSVP)
  • Empresas Farmacéuticas
  • Empresas de Equipos e Instrumentos Médicos
  • Empresas de OTC Cosméticos

No dude en contactarnos

Empresas en España

Empresas en América Latina

Lunes – Domingo

3:00 – 18:00

Hora Estándar Del Este

Únete a nuestros clientes satisfechos

En más de 100 países

AHORRE TIEMPO Y DINERO
CON NOSOTROS

AMPLÍE SU MERCADO

¿QUIERES CAMBIAR
SU AGENTE ANTE LA FDA?

Te lo ponemos fácil


ITB HOLDINGS LLC

390 North Orange Avenue

Suite 2300

Orlando, FL 32801

United States

T : +1 855 389 7344

T : +1 855 510 2240

T : +44 800 610 1577

Skype: itbholdings

FDA Biennial Registration Renewal of 2020

Your next FDA Biennial Registration Renewal is between October 1 and December 31, 2020.

Why wait until October 1, 2020? Prepay now and save extra cash.

www.fda.itbhdg.com | www.m.itbhdg.com | www.itbhdg.com

When you are competing with 300,000+ companies to renew your FDA REGISTRATION, be smart about it.

What to do in the meantime?

Check our Specials

■ Switch U.S. Agent
Limited Offer – $99.00 for Food and Supplements Companies

FDA Registration Number : why pay more for less?

■ Need Food or Supplements Label Review / Design?
Limited Offer – $99.00


What are your options?


ITB HOLDINGS LLC: Select us as your U.S. Agent

Ask for an invoice: Send us an email now

Emails without full company name (as registered), street address, city, postal / zip code, country and telephone number will be automatically deleted as junk or spam.

$99.00: to get you started

❹ Sit back and relax, then receive your FDA Registration Number within 72 hours (Standard Service) or sooner.

Want your company’s FDA Registration Number the same day? Make a request: $198.00.

You cannot find this deal anywhere else.

Contact ITB HOLDINGS LLC at T : +1 855 510 2240 | T : +1 855 389 7344 | T : +44 800 610 1577 | FDA REGISTRATION for 99 Dollars


What’s included?


■ Food Facility Registration

■ Supplement Facility Registration

■ U.S. Agent Service (Foreign Companies)


Any extras? Sure


Prior Notice

■ Foreign Supplier Verification Program – FSVP

■ Registration Certificate

Supplement Facts Label

Nutrition Facts Label


REQUIRED INFORMATION


■ Full company’s name (as registered locally)

■ Street address, city, postal / zip code, state, country

■ Full name of CEO / Manager

■ Telephone number of CEO / Manager

■ Email of CEO / Manager

■ Product details.


EBAY SHOPPERS: CHECKOUT NOW


Companies can export or import Foods | Dietary Supplements | Alcoholic Beverages | to or from the United States as long as the facilities that produce, store, or otherwise handle the products are registered with the FDA (Food and Drug Administration), and prior notice of incoming shipments is provided to the FDA.


Additional Services

■ FDA Registration
■ Product Listing
■ U.S. Agent Service

» Food Canning

» Drugs

» Medical Devices

» OTC Cosmetics

$350.00 | Limited Offer


Thank you for your business

Join our satisfied clients in 100 countries including China | Japan | South Korea | Germany | France | United Kingdom | Canada | Mexico | Spain | Portugal | Italy | Greece | Netherlands | Belgium | Sweden | Australia | New Zealand | Ireland | Poland | Romania | Russia | Ukraine | India | Pakistan | Taiwan | Brazil | United States.

Our representatives are standing by for any question.


Foreign Languages


Español

Deutsch

Français

Italiano

Nederlands

Português

Русский

中文

Contáctenos | お問い合わせ | 联系我们 | Contact met ons opnemen | Contattaci | связаться с нами | हमसे संपर्क करें | اتصل بنا | Contactez-nous | Kontaktieren Sie uns | Kontakta oss | Kontakt z nami | Kontaktujte nás.


MORE INFORMATION?

www.fda.itbhdg.com | www.m.itbhdg.com | www.itbhdg.com


Contact us today.

EXTENDED OFFICE HOURS

3:00 AM – 6:00 PM

Eastern Standard Time – EST

Monday – Sunday

Multilingual and International Team to handle your requests within hours, not days.

LIVE CHAT available on all websites

FOLLOW US

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ITB HOLDINGS LLC
390 North Orange Avenue, Suite 2300
Orlando, FL 32801
United States
T : +1 855 510 2240
T : +1 855 389 7344
T : +44 800 610 1577
Skype Chat: itbholdings
itbholdings | Skype Call

FDA BIENNIAL REGISTRATION RENEWAL

LIMITED OFFER

FOREIGN SUPPLIER VERIFICATION PROGRAM IS NOW REQUIRED

YOUR COMPANY MAY NEED

EIN (Employer Identification Number)

DUNS (Data Universal Numbering System) Number

For $20.00 USD, we can verify any available DUNS Number

FDA Registration of your Food Company
U.S. Agent Service
$99.00 USD
| SAVE 75% TODAY

More than 449,859 facilities from 223 countries and territories are registered with the FDA, including 22 countries with at least 3,000 registrations each.

Exporters and Importers must be registered with the FDA. The USA imports more than 17,377,965 containers of goods every year.

 

FOOD PRODUTCS | COMPANY

 

DIETARY SUPPLEMENTS | COMPANY

 

INITIAL REGISTRATION
DOMESTIC & FOREIGN COMPANIES

Save 75% | INITIAL REGISTRATION | BIENNIAL REGISTRATION RENEWAL

Companies can export or import Foods | Dietary Supplements | Alcoholic Beverages | to or from the United States as long as the facilities that produce, store, or otherwise handle the products are registered with the FDA (Food and Drug Administration), and prior notice of incoming shipments is provided to the FDA.

Food Companies must complete their

 

Biennial Registration Renewal

between October 1 and December 31, 2020,

even if they obtained a new FDA REGISTRATION NUMBER in

■ 2019

■ 2020


REQUIRED INFORMATION :

■ Full company’s name (as registered locally)

■ Street address, city, postal / zip code, state, country

■ Full name of CEO / Manager

■ Telephone number of CEO / Manager

■ Email of CEO / Manager

■ Product details.


SWITCH U.S. AGENT TODAY | SAVE 75%
CLICK ON IMAGE

ITB HOLDINGS LLC as your company's U.S. Agent and contact in both emergencies and routine operations | www.m.itbhdg.com | www.itbhdg.com

We help companies around the world comply with the following :

■ Food Safety Modernization Act (FSMA)

■ Federal Food Drug and Cosmetic Act (FD&C Act)

■ Dietary Supplement Health and Education Act (DSHEA)


Also available:

■ Cosmetics Establishment
■ Alcoholic Beverage Facility
Label, Graphic Design Review
Prior Notice
■ TTB Permit Application
■ USDA Import Permit
■ Export Certificates.


Low-acid Canned Foods (LACF)

Acidified Foods (AF)

Establishment Registration (FCE)

CLICK ON IMAGE | SAVE 75% TODAY

$350.00 USD INITIAL

$300.00 USD ANNUAL

Food Canning Establishment | FDA Registration | Save up to 75% Now | www.itbhdg.com


Vitamins | Nutraceutical | Superfood | Omega-3 Fatty Acids

CLICK ON IMAGE | SAVE 75% TODAY

$99.00 USD INITIAL

$99.00 USD ANNUAL

FDA Registration of your Dietary Supplements Company | www.m.itbhdg.com | www.itbhdg.com


CLICK HERE FOR COSMETICS

FDA Registration of your Cosmetics Company | www.m.itbhdg.com | www.itbhdg.com

$350.00 USD INITIAL

$300.00 USD ANNUAL

SAVE TIME, MONEY


CLICK HERE FOR DRUGS

FDA Registration of your Drugs Company | www.m.itbhdg.com | www.itbhdg.com

$350.00 USD INITIAL

$300.00 USD ANNUAL

SAVE TIME, MONEY


CLICK HERE FOR MEDICAL DEVICES

FDA Registration of your Medical Device Company | www.m.itbhdg.com | www.itbhdg.com

$350.00 USD INITIAL

$300.00 USD ANNUAL

SAVE TIME, MONEY


Simply ask for an invoice


Thank you for your business | Join our satisfied clients in 100 countries including China | Japan | South Korea | Germany | France | United Kingdom | Canada | Mexico | Spain | Netherlands | Belgium | Sweden | Australia | Ireland | Poland | Russia | United States.

Our representatives are standing by for any question. We speak English, Dutch and French for your convenience.

Contáctenos | お問い合わせ | 联系我们 | Contact met ons opnemen | Contattaci | связаться с нами | हमसे संपर्क करें | اتصل بنا | Contactez-nous | Kontaktieren Sie uns | Kontakta oss | Kontakt z nami | Kontaktujte nás.

MORE INFORMATION? Contact us today.

www.fda.itbhdg.com | www.m.itbhdg.com | www.itbhdg.com

EXTENDED OFFICE HOURS : 3:00 AM – 6:00 PM Eastern Standard Time – EST
Monday – Sunday
Multilingual and International Team to handle your requests within hours, not days.

ITB HOLDINGS LLC
390 North Orange Avenue, Suite 2300
Orlando, FL 32801
United States
T : +1 855 510 2240
T : +1 855 389 7344
T : +44 800 610 1577
Skype: itbholdings

HE

FDA Registration of Medical Devices

Premarket Notification 510(k) | Premarket Approval (PMA) | Establishment Registration | www.itbhdg.com

If you’re planning to grow in size, profits, or into new markets, consider expanding to or within the United States.

More than 24,584 domestic (12,848) and foreign (11,736) medical device establishments are registered with FDA.

LIMITED OFFER

✔ Establishment Registration

✔ Medical Device Listing

✔ U.S. Agent Service (Foreign Companies)

✔ $350.00 USD | Initial Registration Fee

✔ $300.00 USD | Annual Fee

Government Fees are extra

Premarket Notification 510(k)

Premarket Approval (PMA)



FDA COMPLIANCE

Owners or operators of companies that are involved in the production and distribution of medical devices intended for use in the United States are required to register annually with the U.S. FDA (Food and Drug Administration) and list the devices that are made there. This process is known as establishment registration.

Companies required to register their establishments and list their devices with the FDA

Firms that

* manufacture
* repackage and relabel
* develop specifications
* reprocess single-use devices
* remanufacture
* manufacture accessories and components sold directly to the end user.


WHAT’S INCLUDED?


⚾ U. S. Agent service

⚾ Medical Device Establishment registration

⚾ Medical Device listing

⚾ Classification of your medical device to determine the proper FDA product code and regulation number.

⚾ Determination of similar (predicate) devices with 510(k) clearance and whether they are suitable for use in your 510(k) submission.

⚾ Completion of 21 sections of the 510(k) application.

⚾ Payment of 510(k) fees on your behalf (when needed).

⚾ Electronic filing of the 510(k) and follow-up with the FDA reviewer.


We speak English, Dutch , French, Spanish, for your convenience.

DEUTSCH | GERMAN

FDA Registrierung

NEDERLANDS | DUTCH

FDA Registratie

ESPAÑOL | SPANISH

Registro FDA

FRANÇAIS | FRENCH

Enregistrement FDA


MORE INFORMATION? Contact us today.

EXTENDED OFFICE HOURS : 3:00 AM – 6:00 PM

Eastern Standard Time – EST

Monday – Sunday

Multilingual and International Team to handle your requests within hours, not days.

LIVE CHAT is available on all websites

 

www.fda.itbhdg.com | www.m.itbhdg.com | www.itbhdg.com

FDA Registration of your Medical Device Company and Products | www.m.itbhdg.com | www.itbhdg.com

ITB HOLDINGS LLC
390 North Orange Avenue, Suite 2300
Orlando, FL 32801
United States
T : +1 855 510 2240
T : +1 855 389 7344
T : +44 800 610 1577
Skype: itbholdings

FDA REGISTRATION

FDA Registration Services | www.m.itbhdg.com | www.itbhdg.com

The United States remains a major importer of food products. American consumers spent 460 Billion dollars per year. So, why not expand your exports there?

If your facility manufactures, packs or holds any of the following foods products, it must be registered with the United States Food and Drug Administration (FDA):

In compliance with the Food Safety Modernization Act (FSMA), the FDA established the following regulations:

■ Foreign and domestic facilities that manufacture or process, pack, hold food are required to register unless food from that facility undergoes further processing (including packaging) by another foreign facility before the food is exported to the United States. However, if the subsequent foreign facility performs only a minimal activity, such as putting on a label, both facilities are required to register.

■ Unless registration is completed, any food product shipped to the United States will be DENIED ENTRY.

■ Foreign Supplier Verification

Importers are now required to have a program to verify that the food products they are bringing into the U.S are safe.

The FDA will increase the number of inspections of foreign facilities and can deny entry to an import if a foreign facility refuses an FDA inspection. Prior Notice submissions will need to include, as an additional element, any country to which the food has been refused entry.

Under the law, there is no fee for the initial FDA inspection. However, the FDA has the authority to assess and collect fees for some types of costs, such as re-inspection-related costs when an initial inspection has identified certain food safety problems ($221 an hour if no foreign travel is required and $289 an hour if foreign travel is required).

Food Canning Establishment Registration (FCE) & Scheduled Process Identification (SID)

Because foods without adequate acidity may allow the growth of microorganisms that cause foodborne illness, the FDA requires companies producing low-acid canned foods (LACF) and acidified foods (AF) to obtain a Food Canning Establishment (FCE) registration before exporting or distributing their food products in the U.S.

Further, these companies must also file documentation for each process used in the production of low-acid canned and acidified foods, in order to obtain Scheduled Process Identification (SID) Numbers.

■ U.S. AGENT Requirement

Foreign Food Facilities must designate an Agent who resides or maintains a place of business in the United States. The U.S. Agent’s responsibility is to be the Foreign Food Facility’s contact in both emergencies and routine operations. A U.S. Agent may also register the Foreign Food Facilities on behalf of foreign companies.

■ Animal and Veterinary

Domestic and foreign establishments that manufacture, repack, or re-label animal drug products in the United States are required to register with the FDA.

Domestic and foreign drug manufacturers, repackers or re-labelers are also required to list all of their commercially marketed drug products. This process is done in conjunction with the human drug registration process.

OUR SERVICES

FDA REGISTRATION


FOOD COMPANIES

☻ Foods for humans

☻ Baby foods

Powdered Infant Formula, Required Nutrients, Notification of New Formula, Ready-to-feed Liquid Formula, Exempt Infant Formula  | www.m.itbhdg.com | www.itbhdg.com

* Powdered Infant Formula

* Required Nutrients

* Notification of New Formula

* Ready-to-feed Liquid Formula

FDA Registration of your pet food company : cat, dog, bird, fish | www.m.itbhdg.com | www.itbhdg.com

Pets Foods for Cat | Dog | Bird | Fish


SUPPLEMENTS COMPANIES

Expand the market of your dietary supplements | www.m.itbhdg.com | www.itbhdg.com

DS CGMP Rule

Botanical Dietary Supplements

Vitamin, Mineral Dietary Supplements

Health Claims


FOOD CANNING ESTABLISHMENTS

FDA Registration of your Food Canning Company | www.m.itbhdg.com | www.itbhdg.com

FCE Registration

SID Filing


COSMETICS COMPANIES

FDA Cosmetics | Perfumes, Lipsticks, Fingernail 
Polishes, Eye and Facial Makeup, Shampoos, Hair Colors, Deodorants, Skin Moisturizers

Perfumes | Lipsticks

Fingernail Polishes | Eye and Facial Makeup

Shampoos | Hair Colors | Deodorants

Skin Moisturizers

Establishment registration

U.S. Agent Service

Sunscreens are listed as Over-the-Counter (OTC) DRUGS, not cosmetics in the United States


MEDICAL DEVICES COMPANIES

Premarket Notification 510(k), Premarket Approval (PMA), Medical Devices Listing

Premarket Notification 510(k)

Premarket Approval (PMA)

Medical Devices Listing

Establishment Registration


DRUGS COMPANIES

Abbreviated New Drug Application (ANDA): Generics, Applications for Over-the-Counter (OTC) Drugs | www.m.itbhdg.com | www.itbhdg.com

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA): Generics

Therapeutic Biologics Applications (BLA)

Applications for Over-the-Counter (OTC) Drugs

Drugs Listing

Establishment Registration


MORE FDA SERVICES


☛ Initial Importer Service

U.S. Agent Service

☛ FSVP Importer Service

☛ Importer of Record Service

Prior Notice


FOREIGN LANGUAGES


DEUTSCH | GERMAN

FDA Registrierung

NEDERLANDS | DUTCH

FDA Registratie

ESPAÑOL | SPANISH

Registro FDA

FRANÇAIS | FRENCH

Enregistrement FDA


COMMODITIES TRADE: FOOD IMPORT-EXPORT

Organic cacao, cocoa, coffee products at the best prices and free shipping

We continue to scour the planet to bring you, the highest quality food products. Sellers and buyers of agricultural commodities are invited to contact us.

Cacao, Cocoa

Organic cacao, cocoa, coffee products at the best prices and free shipping

* Cocoa beans

* Cocoa nibs

* Cocoa liquor

* Cocoa powder

* Cocoa butter

Specialty, Gourmet Coffee

Organic cacao, cocoa, coffee products at the best prices and free shipping


Our representatives are standing by for any question. We speak English, Dutch and French for your convenience.

MORE INFORMATION? Contact us today.

www.fda.itbhdg.com | www.m.itbhdg.com | www.itbhdg.com

EXTENDED OFFICE HOURS : 3:00 AM – 6:00 PM Eastern Standard Time – EST, Monday – Sunday | Multilingual and International Team to handle your requests within hours, not days.

LIVE CHAT available on all websites.

ITB HOLDINGS LLC
390 North Orange Avenue, Suite 2300
Orlando, FL 32801
United States
T : +1 855 510 2240
T : +1 855 389 7344
T : +44 800 610 1577
Skype: itbholdings

Genetically Engineered Food Labeling

Organic vs. GMO | www.m.itbhdg.com | www.itbhdg.com

ORGANIC VS. GMO

The use of Genetic Engineering (GE), or Genetically Modified Organisms (GMOs), is prohibited in organic products.

This means

* an organic farmer can’t plant GMO seeds

* an organic cow can’t eat GMO corn

* an organic soup producer can’t use any GMO ingredients.

Should GMO foods always be labeled so consumers are aware that the product contains genetically modified ingredients?

Despite the prevalence of Genetically Modified Organisms (GMOs) in grocery stores and prepared foods, it remains difficult if not impossible for consumers to determine if the foods they eat contain GMOs.

Which foods contain GMOs?

Corn

Soy

Canola

Sugar beets grown in the U.S. are now genetically engineered,
and they are often used as ingredients in processed foods.

A new form of salmon that is genetically altered to grow to maturity twice as fast as wild salmon is currently undergoing a safety review by the Food and Drug Administration. If approved, it would be the first genetically engineered animal to be marketed.

Potato that is genetically engineered to resist bruising and to have potentially lower levels of acrylamide, a suspected human carcinogen that the vegetable can produce when it is cooked at the high temperatures used to make potato chips and french fries. The FDA hasn’t completed a voluntary safety review for the new GMO potato.

McDonald’s is sticking to its current policy of using only non-GMO potatoes for its fries.

Legislation

Under FDC Act sections 403(a)(1) and 201(n), a food is misbranded if its labeling is false or misleading in any particular, including by failing to disclose facts material with respect to the consequences which may result from use of the food under customary or usual conditions of use.

The FDA has taken the position that bioengineered foods (FDA prefers the term bioengineered to GE) as a class are not materially different from conventional foods, and therefore there is no basis to require labeling that specifies their method of production.

Currently, the FDA requires the labeling of over 3,000 ingredients, additives and processes, but the agency has resisted labels for genetically modified foods.

Even the U.S. Patent and Trademark Office has recognized that these foods are materially different and novel for patent purposes.

Sixty-four countries around the world already require the labeling of GE foods, including all the member nations of the European Union, Russia, Japan, China, Australia and New Zealand.

Would GMO labeling drive up grocery prices?

Mandatory labeling that informs consumers about whether their food contains GMOs would add less than a penny a day to their grocery bills.

Organic vs. Genetically Modified Organisms (GMOs) | www.m.itbhdg.com | www.itbhdg.com

Recent court decision

NON-GMO PRODUCTS

Free Shipping to your home, office or warehouse in several countries

Our representatives are standing by for any question. We speak English, Dutch and French for your convenience.

MORE INFORMATION? Contact us today.

EXTENDED OFFICE HOURS : 3:00 AM – 6:00 PM Eastern Standard Time – EST | Multilingual and International Team to handle your requests within hours, not days.

ITB HOLDINGS LLC
390 North Orange Avenue, Suite 2300
Orlando, FL 32801
United States
T : +1 855 510 2240
T : +1 855 389 7344
T : +44 800 610 1577
Skype: itbholdings

U.S. Agent for Foreign Companies

U.S. AGENT Services | FDA Registration | www.m.itbhdg.com | www.itbhdg.com

U. S. Agent for Foreign Establishments

All foreign establishments or facilities must notify the U.S. Food and Drug Administration (FDA) of the name, address, phone, and email address of their U. S. Agent.

This requirement applies to

■ Food facilities

■ Dietary supplements facilities

■ Food canning establishments

■ Cosmetics establishments

■ Drugs establishments

■ Medical devices establishments.


Responsibilities of the U. S. Agent


* Assist the FDA in communications with the foreign establishment

* Respond to questions concerning the foreign establishment’s products that are imported or offered for import into the United States, and

* Assist the FDA in scheduling inspections of the foreign establishment.

A U.S. Agent may also register the Foreign Food Facilities on behalf of foreign companies.


ITB HOLDINGS LLC as your company’s U.S. Agent for the purpose of FDA REGISTRATION


✓ Since 2009

✓ Clients in 100 countries

✓ Multilingual Professionals

✓ Live Support Chat on websites

$99.00 USD Annual Fee

Free when combined with other services


Additional Services


Importer of Record

Initial Importer

Initial Importer

The initial importer of a medical device must register its establishment with FDA. An initial importer is any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes the final delivery or sale of the device to the ultimate consumer or user, but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package.

ITB HOLDINGS LLC as your company's U.S. AGENT | FDA Registration | www.m.itbhdg.com | www.itbhdg.com


We speak English, Dutch , French, Spanish, for your convenience.

DEUTSCH | GERMAN

FDA Registrierung

NEDERLANDS | DUTCH

FDA Registratie

ESPAÑOL | SPANISH

Registro FDA

FRANÇAIS | FRENCH

Enregistrement FDA



MORE INFORMATION? Contact us today.


EXTENDED OFFICE HOURS

3:00 AM – 6:00 PM Eastern Standard Time – EST

Monday-Sunday.

Multilingual and International Team to handle your requests within hours, not days.

www.fda.itbhdg.com | www.m.itbhdg.com | www.itbhdg.com

ITB HOLDINGS LLC
390 North Orange Avenue, Suite 2300
Orlando, FL 32801
United States
T : +1 855 510 2240
T : +1 855 389 7344
T : +44 800 610 1577
Skype: itbholdings

Always indicate the full name of your company (as registered), street address, city, postal / zip code, country and telephone number if you want a response. Emails without this information will be automatically deleted as spam or junk.

Food Canning Establishment (FCE)

FDA Registration of companies selling foods in metal tins and cans | www.m.itbhdg.com | www.itbhdg.com

Anyone wishing to can low-acid foods must use certified equipment, have received proper training at a “Better Process Control School” and keep extensive records as specified by federal regulations.


Better Process Control School (BPCS)


■ course approved by the Food and Drug Administration as well as the United States Department of Agriculture

■ for processors of acidified and low acid canned foods

■ offered online, 2 day workshop (acidified only) or a 3 1/2 day workshop for the entire course.

■ Participants must pass the exams with a score of 70% or higher to become BPCS certified

1. Food Microbiology of Canning
2. Food Container Handling
3. Food Plant Sanitation
4. Records for Production Protection
5. Principles of Thermal Processing
6. Process Room Instrumentation, Equipment, and Operation.


FDA REGISTRATION


Food Canning Establishment (FCE) Registration | Save up to 35%

$350.00 USD

Limited Offer | Initial

$300.00 USD | Renewal

WHAT’S INCLUDED?

Food Canning Establishment Registration (FCE)

⚾ Scheduled Process Identification (SID)

U.S. Agent Service (Foreign Companies)


 

Why should you register your company?

The global canned food industry is
expected to reach $108 billion by 2022

Innovative product offerings with a focus on convenience, quality and eco-friendliness are expected to drive the market growth.

Companies that manufacture or process, pack, hold low-acid canned foods (LACF) and acidified foods (AF) for human or animal consumption in the U.S. are required to obtain a Food Canning Establishment (FCE) registration before exporting or distributing their food products.

They must also file documentation for each process used in the production of low-acid canned and acidified foods, in order to obtain Scheduled Process Identification (SID) Numbers.

Are subject to the FDA regulations

■ canned vegetables

■ mushrooms

■ some fruits

■ fish

■ acidified products stabilized by heat sterilization treatment (pasteurization of acidified product).

These products are low acid, pasteurized, sterilized or acidified and sold in

■ metal tins & cans canisters

■ drums, pails buckets

■ jars, bottles

■ flexible pouches or tetra paks.

FDA Registration of companies selling foods in metal tins and cans, canisters, drums, pails, buckets, jars, bottles, flexible pouches or tetra paks | www.m.itbhdg.com | www.itbhdg.com


FOREIGN COMPANIES


DEUTSCH | GERMAN

FDA Registrierung

NEDERLANDS | DUTCH

FDA Registratie

ESPAÑOL | SPANISH

Registro FDA

FRANÇAIS | FRENCH

Enregistrement FDA


MORE INFORMATION? Contact us today.


www.fda.itbhdg.com | www.m.itbhdg.com | www.itbhdg.com

Enjoy Live Support Chat on our websites

EXTENDED OFFICE HOURS :
3:00 AM – 6:00 PM
Eastern Standard Time – EST

Monday – Sunday

Multilingual and International Team to handle your requests within hours, not days.

SIMPLY ASK FOR AN INVOICE

ITB HOLDINGS LLC
390 North Orange Avenue, Suite 2300
Orlando, FL 32801
United States
T : +1 855 510 2240
T : +1 855 389 7344
T : +44 800 610 1577
Skype: itbholdings

 

Foreign Supplier Verification

Foreign Supplier Verification

Export your Food Products to the USA

Canadian food and supplements companies based in Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Nova Scotia, Ontario, Prince Edward Island, Quebec, and Saskatchewan, pay less for FDA REGISTRATION. Interested?

Before you ship your food products or dietary supplements to the United States

■ Get an FDA REGISTRATION Number

■ Make sure your labels are FDA Compliant

■ File a Prior Notice


Importers are now required to have a program to verify that the food products they are bringing into the United States are safe.

We can help upon request.

U.S. importers can meet key obligations of the Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals by relying on

■ analyses

■ evaluations and activities

■ performed by other entities in certain circumstances, as long as those

■ importers review and assess the corresponding documentation.


■ The FDA is increase the number of inspections of foreign facilities and can deny entry to an import if a foreign facility refuses an FDA inspection.

Prior Notice submissions include, as an additional element, any country to which the food has been refused entry.

Under the law, there is no fee for the initial FDA inspection. However, the FDA has the authority to assess and collect fees for some types of costs, such as re-inspection-related costs when an initial inspection has identified certain food safety problems ($221 an hour if no foreign travel is required and $289 an hour if foreign travel is required).


We speak English, Dutch , French, Spanish, for your convenience.

DEUTSCH | GERMAN

FDA Registrierung

NEDERLANDS | DUTCH

FDA Registratie

ESPAÑOL | SPANISH

Registro FDA

FRANÇAIS | FRENCH

Enregistrement FDA



MORE INFORMATION? Contact us today.


EXTENDED OFFICE HOURS : 3:00 AM – 6:00 PM Eastern Standard Time – EST | Multilingual and International Team to handle your requests within hours, not days.

ITB HOLDINGS LLC
390 North Orange Avenue, Suite 2300
Orlando, FL 32801
United States
T : +1 855 510 2240
T : +1 855 389 7344
T : +44 800 610 1577
Skype: itbholdings

Exporting Food Products to the USA

Legislation to consider when exporting

ITB HOLDINGS LLC as your U.S. Agent | www.m.itbhdg.com | www.itbhdg.com

Your U.S. Importers who establish and verify compliance with pre-existing Dietary Supplement Current Good Manufacturing Practices (CGMP) regulation will not be required to comply with most of the standard Foreign Supplier Verification Program (FSVP) requirements.

Certain U.S. importers would not have to conduct hazard analyses and would be able to verify their foreign suppliers by obtaining written assurances from their supplier.

U.S. importers are required to identify and evaluate illness data, scientific reports and other known or reasonably foreseeable hazards for each type of food they import to determine if there are any hazards requiring a control. These include:

* Biological hazards, including parasites and disease-causing bacteria

* Chemical hazards, including radiological hazards, pesticide and drug residues, natural toxins, food decomposition, unapproved food or color additives, and food allergens

* Physical hazards, such as glass.

In compliance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), the United States Food and Drug Administration (FDA) established new regulations:

  • Domestic and foreign facilities that manufacture or process, pack, hold food are required to register unless food from that facility undergoes further processing (including packaging) by another foreign facility before the food is exported to the United States. However, if the subsequent foreign facility performs only a minimal activity, such as putting on a label, both facilities are required to register.
  • Unless registration was completed, any food product shipped to the United States will be DENIED ENTRY.

The  FDA Food Safety Modernization Act (FSMA), signed into law on January 4 2011, enables the FDA to better protect public health by strengthening the food safety system. The FSMA amended section 415 of the Federal Food Drug and Cosmetic Act (FD&C Act), 21 U.S.C. § 350d, which requires domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. to register with the FDA.

Under FSMA, all food facilities that are required to register with the FDA under section 415 of the FD&C Act must renew their registration with the FDA, every other year, during the period of time beginning on October 1 and ending on December 31 of each even-numbered year.

If your facility handles any of the included foods, it must be registered with the FDA:

  • Dietary supplements and dietary ingredients
  • Infant formula
  • Beverages (including alcoholic beverages and bottled water)
  • Fruits and vegetables
  • Fish and seafood
  • Dairy products and shell eggs
  • Raw agricultural commodities for use as food or components of food
  • Canned and frozen foods
  • Bakery goods, snack food, and candy (including chewing gum)
  • Live animals
  • Food for animals.

MORE INFORMATION? Contact us today.

EXTENDED OFFICE HOURS : 3:00 AM – 6:00 PM
Eastern Standard Time – EST

Monday – Sunday

$99.00 USD for FDA REGISTRATION of your FOOD COMPANY | LIMITED OFFER.

Most canned food products require a FOOD CANNING ESTABLISHMENT (FCE) Registration. Our fee is then $350.00 USD for the initial registration and $300.00 USD annually.

Multilingual and International Team to handle your requests within hours, not days.

ITB HOLDINGS LLC is the choice for STARTUPS seeking FDA REGISTRATION Services | www.m.itbhdg.com | www.itbhdg.com

ITB HOLDINGS LLC
390 North Orange Avenue, Suite 2300
Orlando, FL 32801
United States
T : +1 855 510 2240
T : +1 855 389 7344
T : +44 800 610 1577
Skype: itbholdings