美国FDA 指导原则 行业指南您需要了解的FDA法规缓解策略以保护食品免受故意掺假(21 CFR Part 121)小实体合规指南(PDF) 英文原版.pdfVIP

Contains Nonbinding Recommendations Mitigation Strategies to Protect Food Against Intentional Adulteration: What You Need to Know About the FDA Regulation: Guidance for Industry Small Entity Compliance Guide Additional copies are available from: Center for Food Safety and Applied Nutrition Food and Drug Administration 5001 Campus Drive College Park, MD 20740 (Tel) 240-402-1700 /FoodGuidances You may submit either 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 FDA-2013-N-1425 listed in the notice of availability that publishes in the Federal Register. U.S. Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition August 2017 1 Contains Nonbinding Recommendations TABLE OF CONTENTS I. INTRODUCTION 4 A. Purpose of this Compliance Guide 5 B. Key Requirements 5 II. WHO MUST COMPLY WITH THE RULE? 6 A. Definitions 6 B. Who is exempt from the requirements for the IA Rule? 7 C. Do I have to comply with the requirements of the IA rule if I am not required to register with the FDA? 9 D. Am