Download or read book FDA Inspections of Domestic Food Facilities written by CreateSpace Independent Publishing Platform and published by Createspace Independent Publishing Platform. This book was released on 2018-07-03 with total page 38 pages. Available in PDF, EPUB and Kindle. Book excerpt: FDA inspections of domestic food facilities.
Download or read book FDA Inspections of Domestic Food Facilities written by United States. Department of Health and Human Services. Office of Inspector General and published by . This book was released on 2010 with total page 31 pages. Available in PDF, EPUB and Kindle. Book excerpt: Each year, more than 300,000 Americans are hospitalized and 5,000 die after consuming contaminated foods and beverages. Recent high-profile outbreaks of foodborne illness have raised serious questions about FDA's inspections process and its ability to protect the Nation's food supply. The Senate Committee on Agriculture, Nutrition, and Forestry requested that the Office of Inspector General (OIG) review the extent to which FDA conducts food facility inspections and identifies violations. FDA inspects food facilities to ensure food safety and compliance with regulations. During an inspection, FDA inspectors may identify potential violations of the Food, Drug, and Cosmetic Act as well as other applicable laws and regulations. Based on the outcome of the inspection, FDA assigns a facility one of three classifications: official action indicated (OAI), voluntary action indicated (VAI), or no action indicated (NAI). In addition, FDA may choose to change a facility's initial classification to another classification under certain circumstances.
Download or read book Enhancing Food Safety written by National Research Council and published by National Academies Press. This book was released on 2010-11-04 with total page 589 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book FDA Investigations Operations Manual written by Food and Drug Administration and published by . This book was released on 2003 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Domestic Food Safety written by United States. General Accounting Office and published by . This book was released on 1989 with total page 40 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Ensuring Safe Food written by Committee to Ensure Safe Food from Production to Consumption and published by National Academies Press. This book was released on 1998-09-02 with total page 209 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book FDA Biotechnology Inspection Guide written by United States. Food and Drug Administration and published by . This book was released on 1991 with total page 62 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Guide to Handling FDA Food Inspections written by Richard Laurence Frank and published by . This book was released on 2002 with total page 124 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Food Inspections written by United States. General Accounting Office and published by . This book was released on 1986 with total page 36 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Oversight of Food Safety Activities written by and published by . This book was released on 2005 with total page 108 pages. Available in PDF, EPUB and Kindle. Book excerpt: GAO has documented many problems resulting from the fragmented nature of the federal food safety system and recommended fundamental restructuring to ensure the effective use of scarce government resources. In this report, GAO (1) identified overlaps in food safety activities at USDA, FDA, EPA, and NMFS; (2) analyzed the extent to which the agencies use interagency agreements to leverage resources; and (3) obtained the views of stakeholders. Several statutes give responsibility for different segments of the food supply to different agencies to ensure that the food supply is safe. The U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) within the Department of Health and Human Services (HHS) have the primary responsibility for regulating food safety, with the Environmental Protection Agency (EPA) and the National Marine Fisheries Service (NMFS) also involved. In carrying out their responsibilities, with respect to both domestic and imported food, these agencies spend resources on a number of overlapping activities, such as inspection/enforcement, training, research, or rulemaking. For example, both USDA and FDA conduct similar inspections at 1,451 dual jurisdiction establishments--facilities that produce foods regulated by both agencies. Under authority granted by the Bioterrorism Act of 2002, FDA could authorize USDA inspectors to inspect these facilities, but it has not done so. Furthermore, USDA and FDA maintain separate training programs on similar topics for their inspectors that could be shared. Ultimately, inspection and training resources could be used more efficiently. GAO identified 71 interagency agreements that the agencies entered into to better protect public health and to coordinate their food safety activities. However, the agencies have weak mechanisms for tracking these agreements that, in some cases, lead to ineffective implementation. Specifically, USDA and FDA are not fully implementing an agreement to facilitate the exchange of information about dual jurisdiction establishments, which both agencies inspect. In addition, FDA and NMFS are not implementing an agreement designed to enable each agency to discharge its seafood responsibilities effectively. GAO spoke with selected industry associations, food companies, consumer groups, and academic experts, and they disagree on the extent of overlap and on how best to improve the food safety system. Most of these stakeholders agreed that laws and regulations should be modernized to more effectively and efficiently control food safety hazards, but they differed about whether to consolidate food safety functions into a single agency.
Download or read book Overseeing the U S food supply steps should be taken to reduce overlapping inspections and related activities testimony before the Subcommittee on the Federal Workforce and Agency Organization Committee on Government Reform House of Representatives written by and published by DIANE Publishing. This book was released on with total page 30 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Imported Foods written by United States. General Accounting Office and published by . This book was released on 1989 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Bacteriological Analytical Manual written by United States. Food and Drug Administration. Division of Microbiology and published by . This book was released on 1969 with total page 180 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making written by Institute of Medicine and published by National Academies Press. This book was released on 1999-07-27 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt: In an effort to increase knowledge and understanding of the process of assuring data quality and validity in clinical trials, the IOM hosted a workshop to open a dialogue on the process to identify and discuss issues of mutual concern among industry, regulators, payers, and consumers. The presenters and panelists together developed strategies that could be used to address the issues that were identified. This IOM report of the workshop summarizes the present status and highlights possible strategies for making improvements to the education of interested and affected parties as well as facilitating future planning.
Download or read book Vulnerabilities in Fda s Oversight of State Food Facility Inspections written by CreateSpace Independent Publishing Platform and published by Createspace Independent Publishing Platform. This book was released on 2018-07-05 with total page 40 pages. Available in PDF, EPUB and Kindle. Book excerpt: Vulnerabilities in FDA's oversight of state food facility inspections.
Download or read book Vulnerabilities in FDA s Oversight of State Food Facility Inspections written by United States. Department of Health and Human Services. Office of Inspector General and published by . This book was released on 2011 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Food Safety and Quality written by United States. General Accounting Office and published by . This book was released on 1992 with total page 76 pages. Available in PDF, EPUB and Kindle. Book excerpt:
