美国FDA 指导原则 外国食品机构或外国政府拒绝检验的行业指南 英文原版.pdfVIP

Contains Nonbinding Recommendations Refusal of Inspection by a Foreign Food Establishment or Foreign Government: Guidance for Industry You may submit electronic or written comments regarding this guidance at any time. Submit electronic comments to . Submit written comments to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number FDA-2017-D-6528 listed in the notice of availability published in the Federal Register . U.S. Department of Health and Human Services Food and Drug Administration Office of Regulatory Affairs Center for Food Safety and Applied Nutrition Center for Veterinary Medicine October 2022 Contains Nonbinding Recommendations Table of Contents I. Introduction II. Background A. Statutory Authority B. Scheduling Foreign Food Establishment Inspections C. Establishment Inspection Activities III. Refusal of Inspection A. Refusal of Inspection by a Foreign Food Establishment i. Refusal by a Foreign Food Establishment to Permit Scheduling of an Inspection ii. Refusal by a Foreign Food Establishment to Permit Conducting an Inspection B. Refusal of Inspection by a Foreign Government i. Refusal by a Foreign Government to Permit Scheduling of an Inspection ii. Refusal by a Foreign Government to Permit Conducting an Inspection IV.FDA Enforcement of Section 807(b) of the Federal Food, Drug, and Cosmetic Act A. Refusal by a Foreign Food Establishment B. Refusal by a Foreign Government V. References 2 Cont