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US FDA Regulation for Food, Medical Devices, Cosmetics and Drugs – I3CGlobal

FDA Food Facility Registration 

The U.S. Food and Drug Administration (FDA) requires both domestic and foreign facilities that manufacture, pack or store food for human consumption in the United States to be registered with the FDA. Hence, this registration is important for the safe and secure food supply in the U.S. 

Step by Step Guide for the FDA Food Facility Registration process is given below

1. Find out If your facility needs to register

All food for human or animal consumption must be processed, packed and held by a registered facility located in the United States.

Certain facilities are exempt from registration, including farms, retail food establishments and certain fishing vessels. You should also know if you qualify for any exemptions.

2. Gather Required Information

Provide the name, physical address (street number) and mailing address of the facility.

  • Name and address Of Parent Company (if any)
  • Contact Information: Your contact information must include the full name of either the owner, operator or agent in charge (include first and last) as well as his title, and place at which he works
  • Emergency Contact: Name the specific person and or phone number.
  • Type of facility: Indicate the variety of food products handled in this establishment

3. Register for an FDA Industry Systems Account

Visit the FDA Industry Systems (FIS) Website: FDA Industry Systems

Sign Up with your email and create a Username & Password Save these credentials as you will use them to log into the registration system and manage your facility’s registration Fill Form Online and Register. Sign in to the FDA Industry Systems with your User ID.

Food Facility Registration Module > Click New Registration.

Completing the necessary details about your facility Configuration and Usage Details.

Verify the provided records and click on submit for registration.

4. Appoint a U.S. Agent (Foreign Facilities)

The agent must be either a representative of the foreign facility’s U.S. owner or consignee and may not reside in California pre-empting law that requires all facilities to have an office address within state lines.

The U.S. agent does not replace the foreign facility in FDA communication but maintains a link between them and all correspondence regarding import shipments will be sent to both parties along with any alerts or warnings they plan on issuing against your shipment. Write the agent information to be included in the registration

5. Obtain a Registration Number

If your FDA registration is submitted and accepted, FDA will provide a unique facility registration number. This is an important number for you to keep track of which needs to be noted when discussing things with the FDA.

6. Keeping Your Registration Current and Up to Date

Facility registrations with the FDA must be renewed every two years between October 1 and December 31 of even-numbered months. If any information you have submitted with your registration changes (facility address, contact information including the U.S. agent), 

7. Compliance and Record-Keeping

Verify that your plant follows all FDA laws and requirements (including GMP, HACCP, and FSMA). Maintain full registration history and correspondence with the FDA

8. Seek Assistance if Needed

If you have questions or need any help with the process, additional resources for registration will be made available on both the fda.dot.gov site and from their Helpdesk. We suggest speaking with a regulatory professional or lawyer to determine what (FDA) may require for those formulations.

Conclusion

One important step you will need to take for your operations to remain safe and legal within the United States is registering your food facility with the FDA. Come prepared with your complete records and follow these steps to ensure a smooth registration process that keeps you in compliance with the FDA. Contact the I3CGLOBAL team to complete the process including issuing an FDA certificate.

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