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 In this section:

        Inspections, Compliance, Enforcement, and Criminal Investigations

Inspection References

                        
                FDA's Remote Oversight Tools
          Inspection Citation
          Inspection Observations
          ORA Outbreak Response Field Guides


                Inspection Guides
          Investigations Operations Manual
          Field Management Directives
          Foreign Inspections
          Nonclinical Laboratories Inspected under Good Laboratory Practices Home
          Inspections, Compliance, Enforcement, and Criminal Investigations
          Inspection ReferencesInspections, Compliance, Enforcement, and Criminal Investigations Inspection References
  	
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    PrintThis 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.

Manuals
	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.FDA Compliance Policy Guides (CPG)
		Contains FDA compliance policy and regulatory action guidance for FDA staffRegulatory Procedures Manual (RPM)Provides FDA personnel with information on internal procedures to be used in processing domestic and import regulatory and enforcement matters.Investigations Operations Manual (IOM)

The IOM is the primary procedure manual for FDA personnel performing inspections and special investigations.

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Guides
	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.[back to top]

Other References
	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

	OEI Development and Maintenance Procedures
		Official Establishment Inventory (OEI) Data Collection Form
		Official Establishment Inventory (OEI) Data Collection Work Instruction
		ORA Establishment Registration and Control Procedure (Formerly FMD# 92)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.[back to top]

Regulatory Information
	General History and Information Pertaining to FDA Regulations

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.
	United States Code
	Government website to search for United States Code.

Foreign Supplier Verification Programs Inspections
	What to Expect During a Foreign Supplier Verification Programs Inspection
	FSVP and Produce Inspections

FDA's Remote Oversight Tools
	Fact Sheets: Remote Regulatory Assessments (RRA)

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                                                                                  Content current as of:
      04/10/2023Inspection References                
                          

                        FDA's Remote Oversight Tools
          Inspection Citation
          Inspection Observations
          ORA Outbreak Response Field Guides


                        Inspection Guides
          Investigations Operations Manual
          Field Management Directives
          Foreign Inspections
          Nonclinical Laboratories Inspected under Good Laboratory Practices
 
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