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

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

 

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