FDA Draft Guidance for Industry Supplemental Questions and Answers Regarding Food Facility Registration
标准简介
Draft Guidance for Industry Supplemental Questions and Answers Regarding Food Facility Registration[附网盘链接]由Food&Drug Administration于之前发布，适用于美国。标准截图
![Draft Guidance for Industry Supplemental Questions and Answers Regarding Food Facility Registration[附网盘链接]](/img/20210914103727ri3lr.jpg)
标准文档说明
标准文档类型为Draft Guidance for Industry Supplemental Questions and Answers Regarding Food Facility Registration[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Contains Nonbinding Recommendations Draft– Not for Implementation Supplemental Questions and Answers Regarding Food Facility Registration: Draft Guidance 1
for Industry This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or we) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact FDA’s Technical Assistance Network by submitting your information at https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm459719.htm. I. INTRODUCTION 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. The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), enacted on January 4, 2011, amended the food facility registration requirements in section 415 of the FD&C Act. FDA first issued a guidance document with questions and answers regarding food facility registration requirements on December 4, 2003. That guidance was issued as Level 2 guidance pursuant to Title 21, Code of Federal Regulations (CFR), Section 10.115 (21 CFR 10.115). The most recent edition of the guidance (the Seventh Edition) was issued as Level 1 guidance pursuant to 21 CFR 10.115 in August 2018, and includes updated questions and answers relating to food facility registration. 1
This guidance has been jointly prepared by the Office of Compliance in the Center for Food Safety and Applied Nutrition, the Office of Surveillance and Compliance in the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the U.S. Food and Drug Administration 3
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