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FDA warning letters about food products : how to avoid or respond to citations /

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...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Frestedt, Joy L.
Formato: Electrónico eBook
Idioma:Inglés
Publicado: London : Academic Press, an imprint of Elsevier, [2017]
Temas:
Acceso en línea:Texto completo
Tabla de Contenidos:
  • 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?