FDA Food Facility Registration

What is FDA？

FDAThe U.S. Food and Drug Administration (FDA) is a federal public health agency responsible for overseeing related matters and is subordinate to...U.S. Department of Health and Human Services（Department of Health and Human Services）。

FDA-regulated product range

1. Human medicines

· Prescription drugs

· Non-prescription drugs (OTC）

· Generic drugs

2. Biological products

· vaccine

· Blood supply

· blood products

3. Medical devices

· From simple instruments such as tongue depressors

· From complex technology products such as pacemakers

4. Products emitting radiation

· Micro-wave oven

· Sunbathing bed

· laser pointer

5. Food

· Food safety

· Food additives (including radiation used in food processing)

· Infant formula

· dietary supplements

· Food utensils

· Containers and Packaging Materials

6. Cosmetics

7. Veterinary products

· Livestock and pet food

· Animal medicines

8. Tobacco products

9. Pigment additives

· Used in food, medicine and cosmetics

An important aspect of the U.S. food safety system

FDAThe organization responsible for regulating U.S. consumption80% Food safety, includingLocal productionandImported food。

Exception: By USDA Regulation

The following products are manufactured by the U.S. Department of Agriculture (USDA).USDARegulation:

1. Meat and meat products

2. Poultry and poultry products

3. catfish

4. Frozen and processed eggs (liquid, dehydrated, etc.)

5. Animal and plant health related matters

Exception: By TTB Regulation

TTB(Alcohol and Tobacco Tax and Trade Bureau) Regulation:

· alcohol content Exceed 7% alcoholic beverages

FDA International Office

General information on food exports to the United States

All food products intended for import into the United States must comply with U.S. domestic product standards.Same requirements,include:

· Food safety requirements

· Good Manufacturing Practices（GMP）、Good Agricultural Practices（GAP or other applicable standards

· Facility Registration

· Labeling requirements

· Special requirements for specific products
Examples include: acidified foods, low-acid foods that are stable at room temperature, milk, fish and shellfish, fruit juices and pulps, etc.

· Complies with the Food Safety Modernization Act（FSMA requirements

In addition, it is also necessary to comply with Prior notice (Prior Notice）system.

You also need to be able to cooperate and accept FDA inspection。

Food facility registration

Why do food facilities need to be registered?

Food facility registration is a necessary procedure for compliance with U.S. law. Relevant regulations can be found in the Code of Federal Regulations (CFR).U.S. Code of Federal Regulations）：

Title 21, Chapter I, Subchapter A, Part 1, Subpart H
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-1/subpart-H?toc=1

The information submitted during registration is helpfulThe FDA understands food businesses within the United States and also helps in the occurrence of...Foodborne disease outbreakorPotential bioterrorism incidentsAt that time, determine the possible source and location of the food.

Who needs to register?

The following types of facilities require registration:

· Manufacturer or processor

· Packaging

· Warehousing facilities

Scope of application

This requirement applies toAll facilitiesThis is not directed at the company or joint venture itself.

For example:

· A company has in different locations 10 facilities

· Export logistics company

· Companies with independent headquarters

Regarding facility registration

· A U.S. agent must be selected (US Agent）

· The system will verify whether the selected U.S. agent agrees to act as the company's agent.

· Once the verification is successful, the system will send an email to the registrant, which includes...Registration number (Registration Number and Personal Identification Number (PIN)

· If any changes occur to the facility registration information, it must be... Within 60 daysUpdate registration information

· If the registered facility undergoes the following changes:

the Address change

the Change of ownership

the Company merger
The original registration must be cancelled, and a new registration must be made using the updated information.

Unique Facility Identifier (UFIDA)UFI)

· according to 21 CFR 1.232(a)(2),since October 1, 2020From now on, both domestic and overseas facilities must provide a [system/mechanism].FDA acceptedUnique Facility Identifier (UFIDA)UFI)。

· The UFI currently recognized by the FDA isDUNS number（Data Universal Numbering System (DUCS)

· DUNS numbers are fromDun & BradstreetAllocation and management.

· Application requiredFor DUNS numbers, please refer to the following link:
https://www.fda.gov/media/143997/download

Regarding the unique facility identification code (UFI) recommendations

· Please useYour own actual addressDo not use information from agents or freight forwarders.

· Do not use the headquarters location;Each facility must have oneDUNS number。

· In the FDA registration applicationLegal name and address of the facilityMust withThe DUNS information is consistent.

· The DUNS number isFreeAnd in You can change it up to 4 times within 90 days.。

DUNS Contact Information

· Telephone：1-866-705-5711

· Mail：ImportSafetySupport@DNB.com

· website：https://importregistration.dnb.com/

Contact information for DUNS in China

· Telephone：400-820-3536

· Mail：inquiryCN@dnb.com

· website：https://www.dnb.com.cn/

Registration Cancellation

· existFDA verification of your facilityUFIBefore verifying the accuracy of the information and confirming that the specific address of the facility corresponding to the UFI matches the address in the registration information, the FDA...Will not confirmYour registration will not provide you with a registration number.

· The FDA will review the submitted documents.UFIVerification is required.
(according to 21 CFR 1.231(a)(3)and(b)(5),as well as D&B(Related requirements)

· since March 10, 2023From now on, all FDA Food Facility Registration (FFR)China did not provide accurate information.Unique Facility Identifier (UFIDA)UFI)All registrations will be cancelled.

· Affected companies are required to make up the difference. UFIAfter receiving the information, you can restore its registration.