FDA Food Facility Registration Form 3537

1

Type of Registration

1a. Registration Type

Domestic Registration Foreign Registration

1b. Initial Registration

Initial Registration Renewal Update / Amendments Cancellation

Registration Number (if renewal/update)

PIN Number (if renewal/update)

Are you the new owner of a previously registered facility?

Yes No

1c. Previous Owner's Title

Previous Owner's Name

Previous Owner's Registration Number

2

Facility Name / Address Information

Facility Name *

Facility Name Suffix

Unique Facility Identifier (UFI / DUNS Number)

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

Your U.S. Agent is Regovant LLC. As your registered FDA agent, Regovant LLC will receive all FDA communications on your behalf. You do not need to fill in this section.

U.S. Agent NameRegovant LLC

U.S. Agent IDWill be provided upon registration

Street Address5830 E 2nd St, Suite 7000

City / State / ZIPCasper, WY 82609

Phone+1 (307) 301-7465

Emailinfo@regovant.com

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

Complete Section 9a for food for human consumption and/or Section 9b for food for animal consumption. Check all applicable product categories and activities.

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	Refrigerated Food Storage	Frozen Food Storage	Processor / Food Processor	Packer / Reconditioner	Manufacturer / Labeler	Repacker / Relabeler	Salvage Operator	Farm / Mixed Farm	Caterer / Catering	Contract Sterilizer	Other Activity

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 Section 7 – U.S. Agent

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.

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

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

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

Registration Submitted