Wednesday, November 23, 2016

Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry (PDF)

U.S. Department of Health and Human Services Food and Drug Administration Office of Foods and Veterinary Medicine 
Center for Food Safety and Applied Nutrition Center for Veterinary Medicine
Office of Regulatory Affairs November 2016

On October 10, 2003, the Food and Drug Administration (FDA or we) issued an interim final rule to implement amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) made by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) (Pub. L. 107-188) (68 FR 58894). Section 415 of the FD&C Act (21 U.S.C. 350d) requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with FDA. This guidance was developed to answer frequently asked questions relating to the registration requirements of section 415 of the FD&C Act/


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