FDA Investigations Operations Manual
FDA Investigations Operations Manual

Author: Food and Drug Administration

Publisher:

Published: 2003

Total Pages: 0

ISBN-13: 9780865879737

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Available now to FDA-regulated organizations, this manual allows facility managers to look at their operation's regulatory compliance through the eyes of the government. Because this is the primary reference manual used by FDA personnel to conduct field investigation activities, you can feel confident you are preparing appropriate planning or action. This manual includes revised instructions regarding the release of information and covers FDA's policies and expectations on a comprehensive range of topics: FDA's authority to enter and inspect, inspection notification, detailed inspection procedures, recall monitoring, inspecting import procedures, computerized data requests, federal/state inspection relationships, discussions with management regarding privileged information, seizure and prosecution, HACCP, bioengineered food, dietary supplements, cosmetics, bioterrorism, and product disposition. The manual also includes a directory of Office of Regulatory Affairs offices and divisions.

Retail Food Safety
Retail Food Safety

Author: Jeffrey Farber

Publisher: Springer

Published: 2014-10-07

Total Pages: 195

ISBN-13: 1493915509

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Currently, there is no one book or textbook that covers all aspects of retail food safety. It is becoming apparent that a number of issues relating to retail food safety have come to the forefront in some jurisdictions of late. For example, a recent USDA risk assessment has pointed out that issues occurring at USA retail appear to be critical in terms of contamination of deli-meat. As well, a large listeriosis outbreak in Quebec pointed to retail cross-contamination as a key issue. In terms of sanitation, a number of advances have been made, but these have not all been synthesized together in one chapter, with a focus on retail. In addition, the whole area of private standards and the Global Food Safety Initiative (GFSI) have come to the forefront of late and these as well will be explored in great detail. Other aspects related to the safety of important food commodities such as seafood, meat, produce and dairy will also be discussed and salient areas addressed.

Enhancing Food Safety
Enhancing Food Safety

Author: National Research Council

Publisher: National Academies Press

Published: 2010-11-04

Total Pages: 589

ISBN-13: 0309163587

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Recent outbreaks of illnesses traced to contaminated sprouts and lettuce illustrate the holes that exist in the system for monitoring problems and preventing foodborne diseases. Although it is not solely responsible for ensuring the safety of the nation's food supply, the U.S. Food and Drug Administration (FDA) oversees monitoring and intervention for 80 percent of the food supply. The U.S. Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources and a piecemeal approach to gathering and using information on risks. Enhancing Food Safety: The Role of the Food and Drug Administration, a new book from the Institute of Medicine and the National Research Council, responds to a congressional request for recommendations on how to close gaps in FDA's food safety systems. Enhancing Food Safety begins with a brief review of the Food Protection Plan (FPP), FDA's food safety philosophy developed in 2007. The lack of sufficient detail and specific strategies in the FPP renders it ineffectual. The book stresses the need for FPP to evolve and be supported by the type of strategic planning described in these pages. It also explores the development and implementation of a stronger, more effective food safety system built on a risk-based approach to food safety management. Conclusions and recommendations include adopting a risk-based decision-making approach to food safety; creating a data surveillance and research infrastructure; integrating federal, state, and local government food safety programs; enhancing efficiency of inspections; and more. Although food safety is the responsibility of everyone, from producers to consumers, the FDA and other regulatory agencies have an essential role. In many instances, the FDA must carry out this responsibility against a backdrop of multiple stakeholder interests, inadequate resources, and competing priorities. Of interest to the food production industry, consumer advocacy groups, health care professionals, and others, Enhancing Food Safety provides the FDA and Congress with a course of action that will enable the agency to become more efficient and effective in carrying out its food safety mission in a rapidly changing world.

A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition
A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition

Author: Stephen M. Kanovsky

Publisher:

Published: 2020-09

Total Pages: 672

ISBN-13: 9781935065876

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FDLI's popular reference book, A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition, provides an introduction to the laws and regulations governing development, marketing, and sale of FDA-regulated products, including topics on food, drugs, medical devices, biologics, dietary supplements, cosmetics, new animal drugs, cannabis, and tobacco and nicotine products. Structured to serve as a reference and as a teaching tool, the book offers practical legal and regulatory fundamentals, and each chapter builds sequentially from the last to provide an accessible overview of the key topics relevant to practitioners of food and drug law and regulation. This book is a standard legal text in law schools and graduate regulatory programs and has been cited as a reference in judicial opinions (including the U.S. Supreme Court). This Seventh Edition includes new sections on controlled substances, compounded drugs, and cannabis and cannabis-derived compounds. It also incorporates the latest amendments to the Federal Food, Drug, and Cosmetic Act, as well as FDA regulations and guidances.

Hi! I'm Your Health Inspector!
Hi! I'm Your Health Inspector!

Author: Mike Campbell

Publisher: Xlibris Corporation

Published: 2010-03-29

Total Pages: 173

ISBN-13: 1450052169

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Current and future food service operators, entrepreneurs, and health enthusiasts are in for an informative read, as author Mike Campbell, a former supervisor of inspectors for the State of Florida, releases through Xlibris, Hi, I’m Your Health Inspector! Hi, I’m Your Health Inspector! is designed to eliminate the mystery and apprehension surrounding the food inspection process, and provides information which can help identify and eliminate food safety hazards. This book explains what the inspector is looking at, and what he is looking for in your operation. There is also a discussion on compliance, as the whole goal of the book is to help you avoid violations, legal action, sanctions, fines, and bad publicity. This manual, based on the FDA Food Code, provides a comprehensive guide to understanding the inspection process, the inspection report, and the violations cited. If, as a food service operator, your goal is to provide your guests with great food and good service, in a clean and sanitary environment, Hi, I’m Your Health Inspector! will prove to be an invaluable tool in meeting that goal. It is an excellent teaching resource for anyone in the industry, or anyone planning a food service career.

Ensuring Safe Food
Ensuring Safe Food

Author: Institute of Medicine and National Research Council

Publisher: National Academies Press

Published: 1998-08-19

Total Pages: 208

ISBN-13: 0309173973

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How safe is our food supply? Each year the media report what appears to be growing concern related to illness caused by the food consumed by Americans. These food borne illnesses are caused by pathogenic microorganisms, pesticide residues, and food additives. Recent actions taken at the federal, state, and local levels in response to the increase in reported incidences of food borne illnesses point to the need to evaluate the food safety system in the United States. This book assesses the effectiveness of the current food safety system and provides recommendations on changes needed to ensure an effective science-based food safety system. Ensuring Safe Food discusses such important issues as: What are the primary hazards associated with the food supply? What gaps exist in the current system for ensuring a safe food supply? What effects do trends in food consumption have on food safety? What is the impact of food preparation and handling practices in the home, in food services, or in production operations on the risk of food borne illnesses? What organizational changes in responsibility or oversight could be made to increase the effectiveness of the food safety system in the United States? Current concerns associated with microbiological, chemical, and physical hazards in the food supply are discussed. The book also considers how changes in technology and food processing might introduce new risks. Recommendations are made on steps for developing a coordinated, unified system for food safety. The book also highlights areas that need additional study. Ensuring Safe Food will be important for policymakers, food trade professionals, food producers, food processors, food researchers, public health professionals, and consumers.