All facilities, both domestic and foreign, that manufacture, process, pack, or store products such as food, beverages, dietary supplements, or ingredients intended for human or animal consumption in the United States are required not only to register their facility with the FDA but also to keep this registration current by renewing it biennially.

Regarding this requirement, we are currently in a critical period for FDA facility registrations: the biennial renewal process. This renewal cycle began on October 1, 2024, and will end on December 31, 2024. According to the Federal Food, Drug, and Cosmetic Act (FD&C Act), this renewal must be completed every two years during even-numbered years (2022, 2024, 2026, etc.), specifically during the last quarter of the year.

It is imperative that the registration renewal is completed before 11:59 p.m. on December 31. Failure to do so will result in the cancellation and removal of the registration, meaning that from 12:00 a.m. on January 1, 2025, you will no longer be able to export or sell products in the U.S. until the registration is reinstated. This can lead to serious logistical issues and financial losses for your company.

The responsibility for completing the renewal falls on the facility owner, a company representative, or an authorized person. For foreign facilities, the FDA representative agent must also be involved in the process.

This process is mandatory for all registered facilities that wish to continue selling their products in the United States. The renewal also applies to facilities registered before October 1 of this year, or those that have made any updates to the registration. It is important to emphasize that updating a registration is not the same as renewing it, so having the proper guidance is crucial to ensure all documents are in order.

Let’s remember that the FDA facility registration includes key information such as the company’s address, owner or responsible person’s details, and the type of activity performed at the facility. For foreign facilities, the information of the FDA U.S. Agent must also be included.

The renewal is essential because it ensures that the FDA has up-to-date information to locate the company in the event of a consumer safety risk. Keeping this database updated is crucial to protect food safety, prevent the distribution of contaminated or mislabeled products, and manage foodborne illnesses. If a problem arises, the FDA can quickly locate the responsible company.

To avoid complications like these, don’t hesitate to contact us! We are here to assist you in the renewal process, ensuring it is completed correctly and on time, so you can continue selling your products in the U.S. legally and without any setbacks.

All facilities, both domestic and foreign, that manufacture, process, pack, or store products such as food, beverages, dietary supplements, or ingredients intended for human or animal consumption in the United States are required not only to register their facility with the FDA but also to keep this registration current by renewing it biennially.

Regarding this requirement, we are currently in a critical period for FDA facility registrations: the biennial renewal process. This renewal cycle began on October 1, 2024, and will end on December 31, 2024. According to the Federal Food, Drug, and Cosmetic Act (FD&C Act), this renewal must be completed every two years during even-numbered years (2022, 2024, 2026, etc.), specifically during the last quarter of the year.

It is imperative that the registration renewal is completed before 11:59 p.m. on December 31. Failure to do so will result in the cancellation and removal of the registration, meaning that from 12:00 a.m. on January 1, 2025, you will no longer be able to export or sell products in the U.S. until the registration is reinstated. This can lead to serious logistical issues and financial losses for your company.

The responsibility for completing the renewal falls on the facility owner, a company representative, or an authorized person. For foreign facilities, the FDA representative agent must also be involved in the process.

This process is mandatory for all registered facilities that wish to continue selling their products in the United States. The renewal also applies to facilities registered before October 1 of this year, or those that have made any updates to the registration. It is important to emphasize that updating a registration is not the same as renewing it, so having the proper guidance is crucial to ensure all documents are in order.

Let’s remember that the FDA facility registration includes key information such as the company’s address, owner or responsible person’s details, and the type of activity performed at the facility. For foreign facilities, the information of the FDA U.S. Agent must also be included.

The renewal is essential because it ensures that the FDA has up-to-date information to locate the company in the event of a consumer safety risk. Keeping this database updated is crucial to protect food safety, prevent the distribution of contaminated or mislabeled products, and manage foodborne illnesses. If a problem arises, the FDA can quickly locate the responsible company.

To avoid complications like these, don’t hesitate to contact us! We are here to assist you in the renewal process, ensuring it is completed correctly and on time, so you can continue selling your products in the U.S. legally and without any setbacks.