FDA Food Facility Registration Checklist

FDA FOOD FACILITY REGISTRATION CHECKLIST

21 CFR PART 1 SUBPART H COMPLIANCE

SECTION 1: REGISTRATION REQUIREMENT DETERMINATION

1.1 Facility Information

1.2 Does Your Facility Need to Register?

You MUST register if your facility is engaged in:

☐ Manufacturing/processing food
☐ Packing food
☐ Holding food

AND the food is for consumption in the United States

☐ Domestic facility - Must register regardless of interstate commerce
☐ Foreign facility - Must register if food is exported to the U.S.

1.3 Exemptions from Registration (21 CFR 1.226)

Your facility is EXEMPT if it is:

☐ Private residence where food is prepared for personal consumption
☐ Non-bottled water collection and distribution (municipal water)
☐ Transport vehicle that holds food only during transport
☐ Farm (as defined in 21 CFR 1.227)
☐ Retail food establishment (primary function is sale to consumers)
☐ Restaurant (prepares and sells food directly to consumers)
☐ Nonprofit food establishment serving food directly to humans/animals
☐ Fishing vessel (not engaged in processing other than on vessel)
☐ Facility regulated exclusively by USDA
☐ Foreign facility whose food undergoes further processing/packaging at another registered facility before reaching U.S. consumer

If ANY box above is checked, registration may not be required. Verify exemption criteria carefully.

SECTION 2: PRE-REGISTRATION REQUIREMENTS

2.1 Unique Facility Identifier (UFI)

Required since October 1, 2020

☐ DUNS Number obtained
OR
☐ Other FDA-recognized UFI obtained

UFI Number: [________________________________]

How to Obtain DUNS Number:

• Visit Dun & Bradstreet: https://www.dnb.com
• Free for businesses requesting for federal purposes

2.2 FDA Unified Registration and Listing System (FURLS) Account

☐ FURLS account created at: https://www.access.fda.gov
☐ Account owner designated: [________________________________]
☐ Additional authorized users added (if applicable)

2.3 Foreign Facility Requirements

For foreign facilities only:

☐ U.S. Agent designated

U.S. Agent Information:

U.S. Agent must:
☐ Reside in the United States OR maintain a place of business in the U.S.
☐ Be available 24/7 for emergency communications

SECTION 3: REGISTRATION INFORMATION (21 CFR 1.232)

3.1 Required Registration Information

☐ Facility Name and Address

• Full legal name of facility
• Physical address (not P.O. Box)

☐ Parent Company Information (if applicable)

• Name: [________________________________]
• Address: [________________________________]

☐ Emergency Contact Information

• Contact Name: [________________________________]
• Phone: [________________________________]
• Email: [________________________________]
• Available 24 hours: ☐ Yes ☐ No

☐ Unique Facility Identifier (UFI)

• DUNS or other recognized UFI: [________________________________]

☐ Facility Type and Function

• See Section 3.2 below

☐ Product Categories

• See Section 3.3 below

☐ U.S. Agent Information (foreign facilities only)

• See Section 2.3 above

3.2 Facility Type/Function Codes

Select all that apply:

Manufacturing/Processing:
☐ Baked goods/dough
☐ Beverages (non-alcoholic)
☐ Candy (non-chocolate)
☐ Cheese/cheese products
☐ Chocolate/cocoa products
☐ Coffee/tea
☐ Dairy products
☐ Dietary supplements
☐ Dressings/condiments
☐ Eggs/egg products
☐ Fats/oils
☐ Fish/seafood products
☐ Food additives/ingredients
☐ Food contact substances
☐ Fruits/fruit products
☐ Grains/grain products
☐ Ice cream/frozen desserts
☐ Infant formula
☐ Jams/jellies/preserves
☐ Meat products (non-USDA)
☐ Nuts/nut products
☐ Pet food/animal feed
☐ Prepared/preserved foods
☐ Snack foods
☐ Soft drinks
☐ Spices/seasonings
☐ Vegetables/vegetable products
☐ Other: [________________________________]

Packing:
☐ Re-packer
☐ Re-labeler
☐ Salvage operator

Holding:
☐ Warehouse/distribution
☐ Cold storage

3.3 Food Product Categories

List specific product categories manufactured, processed, packed, or held:

SECTION 4: REGISTRATION SUBMISSION

4.1 Electronic Submission (Required)

Submission Method:
☐ FDA Industry Systems (preferred): https://www.access.fda.gov
☐ Waiver requested (paper submission only if waiver granted)

Note: Since January 4, 2020, electronic submission is required unless FDA grants a waiver.

4.2 Registration Certification

The registrant must certify that:

☐ The information submitted is true and accurate
☐ The registrant has been authorized to submit the registration
☐ For foreign facilities: U.S. agent has agreed to serve as agent

4.3 Registration Confirmation

Upon successful registration:

SECTION 5: BIENNIAL RENEWAL REQUIREMENTS

5.1 Renewal Period

Renewal required every two years during:

• October 1 through December 31 of even-numbered years
• Next renewal period: October 1, 2026 - December 31, 2026

☐ Renewal calendar reminder set

5.2 Renewal Information to Update/Confirm

☐ Facility name and address
☐ Emergency contact information
☐ All required information from initial registration
☐ U.S. Agent information (foreign facilities)
☐ Food product categories
☐ Unique Facility Identifier (UFI)

5.3 Consequences of Failure to Renew

If registration expires:

• Food from facility may be subject to refusal of admission (imports)
• Food from facility may be subject to detention
• Registration will be cancelled

SECTION 6: REGISTRATION UPDATES AND CANCELLATION

6.1 Required Updates (21 CFR 1.234)

You must update registration within 60 calendar days if:

☐ Facility ceases to operate
☐ Facility changes ownership
☐ Change in facility name
☐ Change in facility address
☐ Change in emergency contact
☐ Change in U.S. Agent (foreign facilities)
☐ Other material changes

6.2 Update Log

6.3 Cancellation (21 CFR 1.235)

Registration must be cancelled if:

☐ Facility ceases to manufacture, process, pack, or hold food for U.S. consumption
☐ Facility changes ownership (previous owner cancels; new owner re-registers)
☐ Facility activity becomes exempt from registration

Cancellation Completed:

SECTION 7: QUALIFIED FACILITY STATUS (FSMA)

7.1 Qualified Facility Determination

A facility may be a "Qualified Facility" under FSMA if:

☐ Very Small Business: Average annual sales < $1 million (inflation adjusted) for previous 3 years
AND majority of sales to qualified end-users

☐ Sales Limitation: Average annual sales to qualified end-users > direct sales to all other purchasers

Qualified End-User means:

• Consumer of the food
• Restaurant or retail food establishment located:
• In same state as facility, OR
• Within 275 miles of facility

7.2 Qualified Facility Attestation

If qualified, submit attestation containing:

☐ Name, address, phone of facility
☐ Contact person
☐ Statement that facility meets requirements

Attestation Due: December 31 of applicable calendar year, and every 2 years

SECTION 8: ADDITIONAL COMPLIANCE REQUIREMENTS

8.1 Prior Notice of Imported Food

For imported food:

☐ Prior notice submitted for each shipment (21 CFR Part 1 Subpart I)
☐ Prior notice system account established

8.2 Recordkeeping Requirements (21 CFR Part 1 Subpart J)

☐ Records established and maintained for:

• Immediate previous source
• Immediate subsequent recipient
• Transporters

☐ Records available within 24 hours (or 8 hours for transporters during transport)

8.3 FSMA Preventive Controls (21 CFR Part 117)

Registered facilities may also be subject to:

☐ Written food safety plan
☐ Hazard analysis and preventive controls
☐ Supply-chain program (if applicable)
☐ Recall plan
☐ Current good manufacturing practices (CGMP)

SECTION 9: COMPLIANCE VERIFICATION CHECKLIST

9.1 Initial Registration Checklist

☐ Registration requirement determination completed
☐ UFI (DUNS number) obtained
☐ FURLS account created
☐ U.S. Agent designated (foreign facilities)
☐ Registration submitted electronically
☐ Registration confirmation received and filed
☐ Registration number recorded

9.2 Ongoing Compliance Checklist

☐ Biennial renewal calendar reminder set
☐ Process established for 60-day updates
☐ Emergency contact information current
☐ U.S. Agent agreement current (foreign facilities)
☐ Registration information verified annually
☐ Qualified facility attestation submitted (if applicable)

9.3 Documentation Retention

Maintain copies of:

☐ Registration confirmation
☐ Registration number
☐ Renewal confirmations
☐ Update confirmations
☐ U.S. Agent agreement (foreign facilities)
☐ Qualified facility attestations (if applicable)

SECTION 10: REGISTRATION SUMMARY

10.1 Current Registration Status

10.2 Responsible Party

10.3 Sign-Off

I verify that this facility's FDA registration is current and accurate:

Signature: ________________________________________

Printed Name: [________________________________]

Title: [________________________________]

Date: [__/__/____]

IMPORTANT REGULATORY NOTES

Registration Timeline

• Initial Registration: Before manufacturing, processing, packing, or holding food for U.S. consumption
• Biennial Renewal: October 1 - December 31 of each even-numbered year
• Updates: Within 60 calendar days of changes
• Cancellation: When facility ceases covered activities

Consequences of Non-Compliance

• Food held at port of entry (imports)
• Refusal of admission (imports)
• FDA may cancel registration
• Facility subject to FDA inspection
• Potential enforcement action

Electronic Submission Requirement

Since January 4, 2020, registration must be submitted electronically unless FDA grants a waiver under 21 CFR 1.245.

SOURCES AND REFERENCES

• 21 CFR Part 1 Subpart H - Registration of Food Facilities
• FDA Food Facility Registration FAQ
• FDA Unified Registration and Listing System (FURLS): https://www.access.fda.gov
• FDA Guidance: Questions and Answers Regarding Food Facility Registration

This template is provided for informational purposes only. Food facility registration requirements may vary based on facility type and activities. Consult with an FDA regulatory attorney for specific compliance guidance.