FDA Food Facility Registration Form 3537

1

Type of Registration

1a. Registration Type

Domestic Registration Foreign Registration

1b. Action Type

Initial Registration Update of Registration Information Biennial Registration Renewal Abbreviated Registration Renewal

Facility Registration Number (if renewal/update)

PIN (if renewal/update)

1d. Are you the new owner of a previously registered facility?

Yes No

Previous Owner's Name

Previous Owner's Registration Number

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U.S. Agent Service Term

Choose your U.S. Agent service term. This is Orionex's service fee — not an FDA government fee, which is $0 for food facility registration. The 2-year term locks in a discount.

1 Year — registration filing + 1 year of U.S. Agent service $300 2 Years — save $150 · best value
Registration filing + 2 years of U.S. Agent service · equivalent to $225/year $600 $450

Note: food facility registrations are renewed with the FDA every two years (the biennial cycle, Oct 1 – Dec 31 of even years). With the 2-year term, Orionex also handles the biennial renewal filing that falls within your term. Includes FDA Food Facility Registration and U.S. Agent service only. Other services, such as FSVP, label review, Prior Notice filing and registration amendments, are not included. Subject to service agreement and eligibility.

2

Facility Name / Address Information

Facility Name *

Unique Facility Identifier (UFI) (optional)

Facility Name Suffix

Street Address, Line 1 *

Street Address, Line 2

City *

State / Province / Territory

ZIP / Postal Code

Country / Area *

Phone Number * (incl. area/country code)

Fax Number (optional, incl. area/country code)

Email Address *

3

Preferred Mailing Address Information

Complete only if different from Section 2

Same as Section 2 (Facility Name/Address Information)

Name

Address, Line 1

Address, Line 2

City

State / Province / Territory

ZIP / Postal Code

Country / Area

Phone Number (incl. area/country code)

Fax Number (optional)

Email Address

4

Parent Company Name / Address Information

If applicable and if different from Sections 2 and 3

Same as:

Section 2 – Facility Address Information Section 3 – Preferred Mailing Address None of the above

Name of Parent Company

Parent Company Suffix

Street Address, Line 1

Street Address, Line 2

City

State / Province / Territory

ZIP / Postal Code

Country / Area

Phone Number (incl. area/country code)

Fax Number (optional)

Email Address

5

Emergency Contact Information

For foreign facilities — FDA will use U.S. agent as emergency contact unless you designate a different one

Same as:

Same as Facility Address (Section 2) Same as U.S. Agent Information (Section 7) None of the above

Individual's Title

Title (Other)

Individual's First Name

Middle Name

Last Name

Individual's Name / Organization

Emergency Contact Phone (incl. area/country code)

Email Address

6

Trade Names

Other names used by the facility (e.g., "also doing business as," "also known as")

Alternate Trade Name #1

Alternate Trade Name #2

Alternate Trade Name #3

Alternate Trade Name #4

7

United States Agent

To be completed by facilities located outside any U.S. state or territory, D.C., or Puerto Rico

The U.S. Agent must reside or maintain a place of business in the United States. The agent agrees to be available 24 hours a day for FDA communications.

Pre-filled by Orionex Regulatory Solutions — This section is completed on your behalf by your authorized U.S. FDA Agent. These details are fixed and cannot be modified.

U.S. Agent Name / Organization *

U.S. Agent ID (optional)

Title (optional)

Street Address, Line 1

Street Address, Line 2

City

State

ZIP Code

Phone Number (incl. area code)

Emergency Contact Phone (incl. area code)

Email Address

8

Seasonal Facility Dates of Operation

Optional — Complete only if facility operations are on a seasonal basis

Harvest 1

Start Month

End Month

Harvest 2

Start Month

End Month

9

General Product Categories

Products for: *

Food for Human Consumption Food for Animal Consumption Both (human and animal food)

Choose above to see the food categories for your facility.

Section 9a — Food for Human Consumption: Type of Activity

Check all food categories and activity types that apply to your facility.

Food Category	Ambient Food Storage Warehouse / Holding Facility	Refrigerated Food Storage Warehouse / Holding Facility	Frozen Food Storage Warehouse / Holding Facility	Acidified Food Processor	Low-Acid Food Processor	Interstate Conveyance Caterer / Catering Point	Contract Sterilizer	Labeler / Relabeler	Manufacturer / Processor	Repacker / Packer	Salvage Operator (Reconditioner)	Farm Mixed-Type Facility	Other Activity Conducted

Other Activity Conducted (specify if "Other" checked above)

Section 9b — Food for Animal Consumption: Type of Activity

Check all food categories and activity types that apply to your facility. If none of the mandatory categories below apply, select box 33.

Animal Food Category	Animal Food Manufacturer / Processor	Animal Food Warehouse / Holding Facility	Acidified Food Processor	Low Acid Food Processor	Contract Sterilizer	Packer / Repacker	Labeler / Relabeler	Salvage Operator (Reconditioner)	Farm Mixed-Type Facility	Other Activity

Other Activity Conducted (specify if "Other" checked above for animal food)

10

Owner, Operator or Agent in Charge Information

If different from all other sections on the form

Same as:

Section 2 – Facility Address Section 3 – Preferred Mailing Section 4 – Parent Company

Name of Entity or Individual who is the Owner, Operator, or Agent in Charge *

Street Address, Line 1

Street Address, Line 2

City

State / Province / Territory

ZIP / Postal Code

Country / Area

Phone Number (incl. area/country code)

Fax Number (optional)

Email Address *

11

Inspection Statement

FDA will be permitted to inspect the facility at the time and in the manner permitted by the Federal Food, Drug, and Cosmetic Act.

I acknowledge and agree to the FDA inspection statement above. *

12

Certification Statement

The owner, operator, or agent in charge of the facility, or an individual authorized by the owner, operator, or agent in charge of the facility, must submit this form. By submitting this form to FDA, the owner, operator, or agent in charge of the facility certifies that the above information is true and accurate. Under 18 U.S.C 1001, anyone who makes a materially false, fictitious, or fraudulent statement to the U.S. Government is subject to criminal penalties.

Signature of Submitter *

Name of Submitter *

Date of Submission

Submitter Role *

A. Owner, Operator, or Agent in Charge (stop here — form is completed) B. Individual Authorized to Submit the Registration

U.S. Agent authorization letter *

This letter appoints Orionex Trading LLC as your U.S. Agent. It is filled in from the details you entered above. Please read it, then type your name to sign it electronically. The letter is in English because it is a U.S. document. A PDF copy is emailed to you after you submit.

Scroll to read the whole letter.

Type your full name to sign *

Your title / position *

I agree and sign this U.S. Agent authorization letter electronically, on behalf of the facility. *

I certify that the information provided in this registration is true and accurate to the best of my knowledge. *

Food Facility Registration

Type of Registration

U.S. Agent Service Term

Facility Name / Address Information

Preferred Mailing Address Information

Parent Company Name / Address Information

Emergency Contact Information

Trade Names

United States Agent

Seasonal Facility Dates of Operation

General Product Categories

Owner, Operator or Agent in Charge Information

Inspection Statement

Certification Statement

U.S. Agent authorization letter *

Registration Submitted