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About Us
Our Services
- By Industry
- By Region
FDA REGISTRATION
Resources
- News and Articles
- EU Ingredients Compliance updates
Contact Us

Expert U.S. Agent services for FDA Communication

The U.S. Food and Drug Administration (FDA) requires food and beverage, cosmetic, medical device, drug, and radiation-emitting device companies located outside of the United States to designate a U.S. Agent when registering with FDA for FDA communication.

Designate Registrar as Your U.S. Agent

How Registrar Corp Can Help

FDA requires your U.S. Agent to have a permanent address in the United States. As your U.S. Agent, our service extends beyond just communicating with FDA on your behalf.

You will also receive:

● Assurance that your facility’s unique facility identifier (UFI), unique device identifier (UDI), or facility establishment number (FEI) is accurate
● Updates to your FDA Registration
● Assistance with Prior Notice filings for your exports to the USA
● Detention Assistance when seeking the release of a detained shipment
● Access to Automated Compliance for Exporters, an innovative supply chain management platform

Note: A DUNS number is the only UFI currently recognized by FDA for food facility registration.

FOOD FACILITY REGISTRATION FORM

Manufacturers involved in the processing, packing, or storage of food, beverages, or dietary supplements must register with the FDA. Additionally, foreign companies are required to designate a U.S. agent.

Our fee for Food Facility Registration, which includes one year of U.S. Agent service, is USD 350 per year.

1 Facility Information

2Contact Information

3Facility Activity

4Review

5Payment Details

Type of Registration

US Domestic Registration
Foreign Facility Registration
Biennial Registration Renewal

Facility Registration Number

If this is a biennial renewal, please enter the registration number. Otherwise, leave this field blank.

Pin

If you intend to change your U.S. Agent, please provide the PIN. Otherwise, leave this field blank.

Name of the company / Facility *

DUNS number (UFI)

Need a DUNS number? You can request one at no cost here Get your DUNS number here

Select Company Type

Street Address

Address Line 1

City

State / Province / Region

Postal Code

Country

I confirm that facility is engaged in the manufacturing/processing, packing, or holding of foods. *

Yes
No

Are you a broker, distributor, importer/filer? *

Yes
No

In accordance with Section 415 of the Federal Food, Drug, and Cosmetic Act, you are not required to register. As defined in 21 CFR 1.225, domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. must register with the FDA. Please be advised that if you choose to proceed with registering, you must comply with all registration requirements and other statutory requirements of the FD&C Act that may apply

Do you take physical possession of the food? *

Yes
No

In accordance with Section 415 of the Federal Food, Drug, and Cosmetic Act, you are not required to register. As defined in 21 CFR 1.225, domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. must register with the FDA. Please be advised that if you choose to proceed with registering, you must comply with all registration requirements and other statutory requirements of the FD&C Act that may apply

Facility Phone Number *

Facility Email *

Describe your products *

Describe the operations you perform *

Do you want to add a Parent Company?

Yes
No

Parent Company Name *

Preferred Mailing Address

Address Line 1

City

State / Province / Region

Postal Code

Country

Do you have different address for Parent company ?

Yes
No

Parent Company Name *

Address Information

Address Line 1

City

State / Province / Region

Postal Code

Country

Consumption Type *

Food for animal consumption
Food for human consumption

Select the operations you perform *

Manufacturer
Low acid food processor
Packer
Acidified food processor
Labeller
Farmed-mix type facility
Contract sterilizer
Interstate conveyance carrier
Ambient storage warehouse
Trader
Refrigerated Ware house
Foreign Exporter
Frozen food Storage

Name of the Facility Responsible person *

Official Title (e.g. CEO, Director ect.) *

Submitter Name

U.S. Agent Service Agreement *

I have read and accept the Service Agreement below.

U.S. Agent Service Agreement

Cosmereg LLC, 7901 4th St. N STE 4016 Tampa/St. Petersburg, FL 33702, USA,privately held company to act as their designated U.S. Agent in accordance with 21 CFR Part 1, Subpart H of the United States Food and Drug Administration (FDA) Code of Federal Regulations (CFR), which requires all foreign facilities that manufacture, process, pack, or hold food for consumption in the United States—including dietary supplements and beverages—to register with the FDA and designate a U.S. Agent to facilitate communication, as mandated by the Bioterrorism Act and the Food Safety Modernization Act (FSMA).

Through this agreement, the Company authorizes Cosmereg to act as their designated U.S. Agent in all communication with the FDA. The company hereby agrees for Cosmereg to identify itself as the designated U.S. Agent for the Company before the FDA, to communicate with the FDA on the Company’s behalf, and to discuss protected information with the FDA, relating to the Company or its products.

Services Rendered

As the designated U.S. Agent for the Company, Cosmereg agrees to:

- Act as an intermediary for communication between the FDA and the foreign business;
- Answer any questions that the FDA may have about the Company or its products in a timely fashion;
- Help the FDA to coordinate inspections of the foreign business’s manufacturing, processing, packaging, storage or other sites;
- Receive information from the FDA, in the case that the FDA is not able to contact the foreign business directly.

Our U.S. Agent Agreement includes only the above listed U.S. Agent responsibilities.

Please note that the U.S. agent has no responsibility related to the reporting of adverse events. We provide this service in addition to our US Agent service.

Company warrants that information provided are truthful and accurate. It remains the Company’s responsibility to update any change in the provided information.

Company acknowledges that Cosmereg LLC is acting as U.S. Agent between the Company and the Food and Drug Administration and has no involvement or specific knowledge of the Company’s products.

Company will not hold Cosmereg liable for any negligence and/or damages whatsoever including but not limited to any liability arising with respect to the performance of the Company’s products.

In order to perform these functions in accordance with FDA regulations, the Company agrees to provide Cosmereg with information, including:

- Information regarding any new products that are intended to be marketed in the U.S., or any alterations to products that are already available for sale and are listed with the FDA (changes to formulations, change of product name, etc.).
- Any alterations to the Establishment registration, including (but not limited to) changes to its address, telephone number, ownership or purpose.

Terms of Sale

This agreement covers one full year of U.S. Agent service. This includes a maximum of 15 hours of service at a fixed rate of USD 350 paid annually between October and December.
Annual renewal of this agreement will be completed four weeks prior to the date of commencement of the next year of service.
The Company agrees to pay 100% of the fee upfront.
This service shall renew automatically each year. In the event that the Company should wish to end this agreement and not renew the U.S. Agent service, they must provide written notice to Cosmereg at least seven (7) working days prior to the renewal date.
In case of any breach of terms Cosmereg has the right to terminate the services with seven days advance notice. In case of non-payment for renewal of services, Cosmereg may revoke all the provided services such as U.S Agent appointment, registration, listing or any other such services and Cosmereg will not be responsible for any loss faced by Company as result of such action.
Either party (the Company or Cosmereg) has the right to terminate this agreement at any time. To do so, they must provide notice by registered mail or through an email sent with a receipt acknowledgement. No refund shall be provided in the event that this service is terminated prior to completion of one full year of service.

Regulations for confidentiality and data protection shall be followed at all times. Cosmereg shall not share confidential information with the FDA, or any other party, without prior approval from the Company.

Cosmereg is not affiliated or associated to the FDA.

This agreement is subject to U.S. regulation. Should any conflict or dispute arise, relating to this agreement or the services detailed above, this shall be resolved in the state of Florida, USA.

Company shall hold Cosmereg harmless from and will fully indemnify Cosmereg for any and all claims for penalties, and/or other charges or claims of whatever nature, including fees assessed by FDA or other U.S. government agencies, in connection with Agent’s services.

I have read and fully understand this document. I am aware of my rights and obligations as detailed above. I wish to contract the services of Cosmereg as the designated U.S. Agent in accordance with FDA regulations. I am legally authorized to enter into this agreement on behalf of the Company.

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Food facility registration *

Basic Price - $350.00
Additional Facility-1 - $100.00
Additional Facility-2 - $100.00
Additional Facility-3 - $100.00
Basic Label Review (optional) - $295.00
Advanced Label Review (optional) - $595.00

The US Agent service is an annual service, and it includes biannual facility registration at no additional cost.

Total

$0.00

Checkout *

Card Number

Expiration Date

Security Code

US FDA Regulations

FDA MoCRA Cosmetic Regulations
U.S. FDA Drug Services
FDA food regulations
US FDA Dietary Supplement Regulations
USA Medical Devices
US FDA Agent
COSMETIC regulatory SERVICES
Mocra cosmetics

Health Canada Regulations

Cosmetic Regulations Canada
Natural Health Product (NHP) Regulations Canada
Canada Medical Devices

EU/UK Regulations

EU Cosmetic Regulations
CPSR (Cosmetic Product Safety)
EU UK Responsible Person

CONTACTS

Tampa/St.Petersburg, USA
+17273509380
London, UK
+442033182439
Seoul, South Korea
00308 491 0226
Kakaotalk ID: Cosmereg

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