FDA Draft Guidance for Industry Refusal of Inspection by a Foreign Food Establishment or Foreign Government
标准简介
Draft Guidance for Industry Refusal of Inspection by a Foreign Food Establishment or Foreign Government[附网盘链接]是FDA于过去发布的FDA标准，适用于US。标准截图
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标准文档说明
标准文档类型为Draft Guidance for Industry Refusal of Inspection by a Foreign Food Establishment or Foreign Government[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
Draft - Not for Implementation Refusal of Inspection by a Foreign Food Establishment or Foreign Government: 1
Guidance for Industry This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or we) on this topic.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 the FDA staff responsible for this guidance as listed on the title page. I. Introduction This guidance provides information for foreign food facilities subject to our inspection as well as foreign governments on how we interpret “refuses to permit entry … to inspect” a foreign food establishment, pursuant to section 807(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384c(b)). The examples used in this guidance are not intended to serve as an exhaustive list. Rather, they illustrate situations that we may encounter in preparing for and conducting inspections. Terms used in this guidance include: • The term “U.S.” refers to the United States. • The pronouns “we” and “our” refer to FDA. • The term “food” means: (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article. (Section 201(f) of the FD&C Act (21 U.S.C. 321(f)). • The term “foreign food establishment” or “establishment” is used in this guidance to refer to a foreign factory, warehouse, or other establishment that manufactures, processes, packs, or holds, food. “Establishments” as used in this guidance include farms (as defined in 21 CFR 1.227 and 112.3). • The term “owner, operator, or agent in charge” is used in this guidance to refer to the owner, operator, or agent in charge of the foreign food establishment, or an individual authorized by the owner, operator, or agent in charge of the foreign 1 This guidance has been prepared by the Office of Compliance in the Center for Food Safety and Applied Nutrition in cooperation with the Center for Veterinary Medicine and the Office of Regulatory Affairs. 3
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