FDA CPG Sec 100.250 Food Facility Registration (Human and Animal Food)

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CPG Sec 100.250 Food Facility Registration (Human and Animal Food)[附网盘链接]是FDA于当前发布的FDA标准,适用于United States。

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CPG Sec 100.250 Food Facility Registration (Human and Animal Food)[附网盘链接]
CPG Sec 100.250 Food Facility Registration (Human and Animal Food)[附网盘链接](截图)

 

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Guidance for FDA Staff

Compliance P olicy Guide Sec. 100.250 F ood Facility Registration – Human and Animal Food This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the telephone number listed on the title page of this guidance. I. Introduction: *The purpose of this document is to provide guidance for FDA staff on food facility registration under section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350d), including the requirement that certain human and animal food facilities register with FDA, the requirement that registered facilities biennially renew their registrations with FDA, and FDA’s authority to suspend a food facility’s registration. FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. The term food, when used in this document, has the meaning specified in 21 CFR 1.227(b)(4) and refers to both food for humans and food for animals. II. Background: Food Facility Registration Section 305 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) (Pub. L. 107-188) amended the FD&C Act by adding section 415, which established requirements for food facilities to register with FDA. Under section 415 of the FD&C Act (21 U.S.C. 350d), the owner, operator, or agent in charge of a domestic or foreign facility that manufactures, processes, packs, or holds food for human or animal consumption in the United States is required to register the facility with FDA, unless an exception applies (see 21 3

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