ABSTRACT

Resiliency Roadmap for FDA Inspectional Oversight   [open pdf - 6MB]

From the Background: "The U.S. Food and Drug Administration [FDA] protects the public health by ensuring the safety, effectiveness and security of human and veterinary drugs, medical devices, vaccines and other biological products for human use. The agency also is responsible for the safety and security of our nation's human and animal food supply, cosmetics, dietary supplements, products that emit electromagnetic radiation, and for regulating tobacco products. FDA uses many tools in its oversight of these products. Inspections are an important part of our toolkit and are part of a comprehensive approach to carrying out our oversight responsibilities. [...] Manufacturers of FDA-regulated commodities maintain primary responsibility for ensuring that the products reaching American consumers are safe and of high quality. Manufacturers and processors are generally required to employ a robust quality management system, also referred to as Current Good Manufacturing Practice (CGMP), or as 'preventive controls' in the food industry, to ensure their products are safe and suitable for the U.S. consumer. FDA's role in conducting periodic surveillance inspections, and when using other oversight tools, is to verify that these quality systems are established and operating as required. FDA also conducts inspections to verify that other regulated entities, such as those involved in the conduct and reporting of FDA-regulated research, are complying with regulatory requirements. If problems are found, FDA uses a variety of oversight and enforcement tools to ensure corrections are made, including additional inspections."

Publisher:
Date:
2021-05
Copyright:
Public Domain
Retrieved From:
U.S. Food and Drug Administration: https://www.fda.gov/
Format:
pdf
Media Type:
application/pdf
URL:
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