The FD&C Act (Federal Food, Drug, and Cosmetic Act) requires food facilities who manufacture, process, pack, or hold food for human or animal consumption in the U.S. to register with the FDA. In addition, the FSMA (Food Safety Modernization Act) added new provisions to the FD&C that include:
- Facilities are required to provide the FDA with assurance that they will be permitted to inspect their facility (in accordance with the FD&C Act)
- Facilities are required to renew their registration every other year
- The FDA now has the authority to suspend a facility’s registration
The new guide explains which types of facilities are required to register and how and when to do so. It also provides the consequences if a facility fails to register or renew as required, including when the FDA can suspend a facility’s registration and the effect of a suspension order.
The FDA has also revised their Food Facilities Registration webpage with a flowchart to assist facilities in determining if they are a retail food establishment or not, which could result in an exemption to the filing requirement.
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