美国FDA行业指南：FDA基于“联邦食品、药品和化妆品法案”第414和704条款的文件记录检查权限(英文版).pdfVIP

Contains Nonbinding Recommendations Guidance for Industry FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, and Cosmetic Act Additional copies are available from: Outreach and Information Center, HFS-009 Center for Food Safety and Applied Nutrition Food and Drug Administration 5100 Paint Branch Parkway College Park, MD 20 740 (Tel) 1-888- 723-3366 /FoodGuidances You may submit electronic or written comments regarding this guidance at any time. Submit electronic comments to . Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register . 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 April 2014 Contains Nonbinding Recommendations Table of Contents I. Introduction II. Background III. Questions and Answers 2 Contains Nonbinding Recommendations Guidance for Industry1 FDA Records Access Authority Under Sections 414 an