Inspection References
This page includes information provided to FDA investigators and inspectors to assist them in their daily activities. It also includes links to the inspection references that were previously available on Gold Disk. For information on Gold Disk can be found at History of Gold Disk.
Resources used by FDA investigators and inspectors in their daily activities.
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Compliance Manuals
FDA's Compliance Programs provide instructions to FDA personnel for conducting activities to evaluate industry compliance with the Federal Food, Drug, and Cosmetic Act and other laws administered by FDA. For tobacco related information please visit the tobacco guidance page.
Includes documents, lists, policies, programs, and statements relating to Compliance References used by FDA personnel.-
Compliance Program Manual (CPM)
Provides instructions to FDA personnel for conducting activities to evaluate industry compliance with the Federal Food, Drug, and Cosmetic Act and other laws administered by FDA.
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FDA Compliance Policy Guides (CPG)
Contains FDA compliance policy and regulatory action guidance for FDA staff
Provides FDA personnel with information on internal procedures to be used in processing domestic and import regulatory and enforcement matters.
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Investigations Operations Manual (IOM)
The IOM is the primary procedure manual for FDA personnel performing inspections and special investigations.
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Search All Guidance Documents
Collection of guidance documents that represent the FDA's current thinking on topics. -
Inspection Guides
Guidance documents written to assist FDA personnel in applying FDA's regulations, policies and procedures during specific types of inspection or for specific manufacturing processes. -
Foreign Inspections - Guide to International Inspections and Travel
Procedure manual for FDA personnel performing inspections and other FDA-related activities abroad. -
Guide to Inspections of Quality Systems (QSIT)
Guidance to the FDA field staff on a new inspectional process that may be used to assess a medical device manufacturer's compliance with the Quality System Regulation and related regulations.
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Field Management Directives
The primary vehicle for distributing procedural information/policy on the management of Office of Regulatory Affairs (ORA) field activities. -
Official Establishment Inventory Information
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FDA Food Code
A model that assists food control jurisdictions at all levels of government by providing them with a scientifically sound technical and legal basis for regulating the retail and food service segment of the industry. -
FDA Food Safety Modernization Act (FSMA)
The FDA Food Safety Modernization Act (FSMA), the most sweeping reform of our food safety laws in more than 70 years, was signed into law by President Obama on January 4, 2011. It aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it. -
Bad Bug Book (Second Edition) - Foodborne Pathogenic Microorganisms and Natural Toxins Handbook
Provides current information about the major known agents that cause foodborne illness. -
Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations
Lists biological products, including any biosimilar and interchangeable biological products, licensed by FDA under the Public Health Service Act (the PHS Act). -
FDA Forms
All forms used by the FDA in PDF format. -
Medical Device GMP Reference Information
CDRH page with information on Good Manufacturing Practices (GMP) for medical devices. -
Approved Drug Products with Therapeutic Equivalence Evalutions (Orange Book)
Identifies drug products approved on the basis of safety and effectiveness by FDA under the Federal Food, Drug, and Cosmetic Act and related patent and exclusivity information.
General History and Information Pertaining to FDA Regulations
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Electronic Code of Federal Regulations (e-CFR)
Title 21, Chapter 1 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration and based mainly off the Federal Food, Drug, and Cosmetic Act. -
Laws Enforced by FDA
Resources about legislation affecting the FDA. -
Federal Food, Drug, and Cosmetic Act (FD&C Act)
Information on and links to the FD&C Act. -
Food and Drug Administration Safety and Innovation Act (FDASIA)
The Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law on July 9, 2012, expands the FDA’s authorities and strengthens the agency's ability to safeguard and advance public health by:- Giving the authority to collect user fees from industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biological products;
- Promoting innovation to speed patient access to safe and effective products;
- Increasing stakeholder involvement in FDA processes; and
- Enhancing the safety of the drug supply chain.
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United States Code
Government website to search for United States Code.
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