This guidance is intended to assist industry and the Food and Drug Administration (FDA) staff by recommending standards for accrediting third-party certification bodies for the voluntary third-party certification program established under the FDA Food Safety Modernization Act (FSMA). The guidance serves as a companion document to the implementing regulations in 21 CFR parts 1, 11, and 16 that establish the framework, procedures, and requirements for accreditation bodies and third-party certification bodies for this program.
The Reportable Food Registry (RFR or the Registry) was established by Section 1005 of the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85), which amended the Food, Drug, and Cosmetic Act (FD&C Act) by creating a new Section 417, Reportable Food Registry [21 U.S.C. 350f].
All recalls monitored by FDA are included in the Enforcement Report once they are classified. Information about how to navigate the report and for definitions of the report labels are found on the Enforcement Report Navigation and Definitions page.
If your product is detained without physical examination, you have the right to provide evidence to FDA in an attempt to overcome the appearance of the violation. If you do not provide evidence to FDA, or if the information you provide is not sufficient to overcome the appearance of the violation, your product is subject to refusal into the United States. Visit the Detention and Hearing page for more information on this process. Contact the compliance officer listed on your FDA Notice of Action if you have questions related to the detention.