نامه‌های هشدار FDA درباره محصولات غذایی: چگونه از ارجاعات جلوگیری کنیم یا به آن‌ها پاسخ دهیم

__FDA Warning Letters About Food Products: How to Avoid or Respond to Citations__ uses examples of FDA warning letters about food products as training tools to discuss important quality and manufacturing issues encountered by food companies around the world as they bring food products into the US market. Focused specifically on FDA warning letters surrounding new dietary ingredients and dietary supplements, the book first introduces FDA warning letters in general. Each chapter then focuses on specific issues identified, including HAACP/quality systems, imports/exports, food contact issues, etc. This book helps the food industry train professional team members (across the spectrum of experience levels) to avoid common issues often cited in warning letters. It serves both as an authoritative reference on the common types of warning letters issued to food companies today, and as a guide to best practices for food manufacturers. * Includes a range of specific warning letters as case studies and examples of method application * Synthesizes often complex information into a clear presentation of FDA warning letters and how to deal with them * Describes techniques and methodologies to guide readers to the solution most appropriate for their scenario Content: Front Cover FDA WARNING LETTERS ABOUT FOOD PRODUCTS FDA WARNING LETTERSABOUT FOOD PRODUCTS: HOW TO AVOID OR RESPOND TO CITATIONS Copyright Contents Acknowledgments 1 -- History of FDA, Food Regulations, and Warning Letters to Food Companies 1.1 FOOD AND DRUG ADMINISTRATION HISTORY 1.2 FOOD REGULATIONS 1.3 GUIDANCE DOCUMENTS FOR FOOD COMPANIES 1.4 FOOD AND DRUG ADMINISTRATION ENFORCEMENT ACTIVITIES 1.5 WARNING LETTER PROCESS 1.6 FOOD WARNING LETTER EXAMPLES (DOMESTIC) 1.6.1 Warning Letters About Dietary Supplements Containing Ephedra 1.6.2 Warning Letters About Weight Loss Products1.6.3 Warning Letters About Front-of-Package Nutrition Labeling 1.6.4 Warning Letters About Caffeinated Alcoholic Beverages 1.7 WARNING LETTER EXAMPLES (INTERNATIONAL) 1.8 PUBLICATIONS 1.9 CONCLUSIONS 1.10 QUESTIONS TO TEST UNDERSTANDING 2 -- Introduction to Quality Systems 2.1 GOOD MANUFACTURING PRACTICES AND QUALITY SYSTEM CONTROLS 2.2 REGULATIONS AND GUIDANCE DOCUMENTS 2.2.1 History of Food Quality Systems and Current Good Manufacturing Practice Regulations 2.2.2 21CFR110-Current Good Manufacturing Practices Regulations 2.2.3 Guidance Documents for Food Quality Standards and Current Good Manufacturing Practices2.2.3.1 Bottled Water 2.2.3.2 Infant Formula 2.2.4 Food and Drug Administration Guidance Documents: Complexity, Diversity, and Modernization 2.3 QUALITY SYSTEM WARNING LETTER EXAMPLES 2.3.1 Seafood Hazard Analysis and Critical Control Points 2.3.2 Cheese Production 2.3.3 Food Labeling 2.3.4 Misbranded Seafood 2.3.5 Misbranding for "Food Allergy" Information 2.3.6 Insanitary Conditions 2.4 PUBLICATIONS 2.4.1 Food Quality and Safety Management Systems 2.4.2 Improving Food Quality Management Systems in the Bakery2.4.3 Food Quality System Costs and Benefits 2.4.4 A Food Quality Management System Conceptual Model 2.5 CONCLUSIONS 2.6 QUESTIONS TO TEST UNDERSTANDING References 3 -- Hazard Analysis and Critical Control Points 3.1 HAZARD ANALYSIS AND CRITICAL CONTROL POINTS PRINCIPLES 3.2 DEVELOPING A HACCP PLAN 3.3 REGULATIONS AND GUIDANCE DOCUMENTS 3.3.1 Dairy Grade A Voluntary HACCP 3.3.2 Juice HACCP 3.3.2.1 "Juice HACCP"-FDA Webpage and References 3.3.2.2 Juice HACCP and the Food Code 3.3.2.3 Juice HACCP: Internal Audits and FDA Inspections3.3.2.4 Juice HACCP Regulator Training 3.3.2.4.1 SANITATION CONTROL 3.3.2.4.2 INITIAL INTERVIEWS 3.3.2.4.3 PLANT TOUR AND FLOW DIAGRAM 3.3.2.4.4 RECORDS REVIEW 3.3.2.4.5 SAMPLE COLLECTION, MICROBIAL 5-LOG REDUCTION, AND TEST VALIDATION REQUIREMENTS 3.3.2.4.6 MANDATORY RECORDS AND DATE SELECTION 3.3.2.4.7 HACCP PLAN FRAUD/FALSIFICATION 3.3.2.4.8 SANITATION MONITORING 3.3.2.4.9 DOCUMENTING OBJECTIONABLE CONDITIONS 3.3.2.4.10 IMPORTER INSPECTIONS 3.3.3 Retail and Food Service HACCP 3.3.4 Seafood HACCP 3.4 WHAT IS HARPC?

FDA Warning Letters About Food Products: How to Avoid or Respond to Citations uses examples of FDA warning letters about food products as training tools to discuss important quality and manufacturing issues encountered by food companies around the world as they bring food products into the US market.

Focused specifically on FDA warning letters surrounding new dietary ingredients and dietary supplements, the book first introduces FDA warning letters in general. Each chapter then focuses on specific issues identified, including HAACP/quality systems, imports/exports, food contact issues, etc.

This book helps the food industry train professional team members (across the spectrum of experience levels) to avoid common issues often cited in warning letters. It serves both as an authoritative reference on the common types of warning letters issued to food companies today, and as a guide to best practices for food manufacturers.

• Includes a range of specific warning letters as case studies and examples of method application
• Synthesizes often complex information into a clear presentation of FDA warning letters and how to deal with them
• Describes techniques and methodologies to guide readers to the solution most appropriate for their scenario

FDA Warning Letters About Food Products: How to Avoid or Respond to Citations uses examples of FDA warning letters about food products as training tools to discuss important quality and manufacturing issues encountered by food companies around the world as they bring food products into the US market. Focused specifically on FDA warning letters surrounding new dietary ingredients and dietary supplements, the book first introduces FDA warning letters in general. Each chapter then focuses on specific issues identified, including HAACP/quality systems, imports/exports, food contact issues, etc. This book helps the food industry train professional team members (across the spectrum of experience levels) to avoid common issues often cited in warning letters. It serves both as an authoritative reference on the common types of warning letters issued to food companies today, and as a guide to best practices for food manufacturers -- Source other than the Library of Congress