Inspection References

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</header> <div class="col-md-8 col-md-push-2" role="main"> <p>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 <a href="/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/history-gold-disk" target>History of Gold Disk</a>.</p>  <p>Resources used by FDA investigators and inspectors in their daily activities.</p> <div class=" panel-group" id="accordion_881833" role="tablist" aria-multiselectable="true"> <div title="Manuals" open="yes" class=" panel panel-default fda-accordion-panel"> <div class="panel-heading" role="tab" id="heading_674512e2d65a7"> <h2 class="panel-title"> <a role="button" data-toggle="collapse" data-parent href="#674512e2d65a7" aria-controls="674512e2d65a7">Manuals</a> </h2> </div> <div id="674512e2d65a7" class="panel-collapse collapse in" role="tabpanel" aria-labelledby="heading_674512e2d65a7"> <div class="panel-body"> <ul> <li> <h3><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="438ea444-82c8-44b7-85bc-c6e05a55204d" href="/inspections-compliance-enforcement-and-criminal-investigations/compliance-manuals" title="Compliance Manuals">Compliance Manuals</a></h3> 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 <a href="/tobacco-products/rules-regulations-guidance/guidance">tobacco guidance</a> page.<br> <br> Includes documents, lists, policies, programs, and statements relating to Compliance References used by FDA personnel. <ul> <li> <h4><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="8d358f3e-fcb2-40f4-9152-c57f8314b7f9" href="/inspections-compliance-enforcement-and-criminal-investigations/compliance-manuals/compliance-program-manual" title="Compliance Program Manual ">Compliance Program Manual (CPM)</a></h4> 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.</li> </ul> <ul> <li> <h4><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="7672fa61-c4a4-4369-9d00-02b90c070a6d" href="/inspections-compliance-enforcement-and-criminal-investigations/compliance-manuals/manual-compliance-policy-guides" title="Manual of Compliance Policy Guides">FDA Compliance Policy Guides (CPG)</a></h4> Contains FDA compliance policy and regulatory action guidance for FDA staff</li> </ul> <ul> <li> <h4><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="29204004-1927-42e8-863e-df235558565b" href="/inspections-compliance-enforcement-and-criminal-investigations/compliance-manuals/regulatory-procedures-manual" title="Regulatory Procedures Manual">Regulatory Procedures Manual (RPM)</a></h4> </li> </ul> <p>Provides FDA personnel with information on internal procedures to be used in processing domestic and import regulatory and enforcement matters. </p> </li> </ul> <h4><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="037ecf69-98d2-40e8-9129-0659bf51d268" href="/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/investigations-operations-manual" title="Investigations Operations Manual">Investigations Operations Manual (IOM)</a></h4> <p>The IOM is the primary procedure manual for FDA personnel performing inspections and special investigations. </p> <p><a href="#top">[back to top]</a></p> </div> </div> </div> <div title="Guides" open="no" class=" panel panel-default fda-accordion-panel"> <div class="panel-heading" role="tab" id="heading_674512e2d6e48"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#674512e2d6e48" aria-controls="674512e2d6e48">Guides</a> </h2> </div> <div id="674512e2d6e48" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_674512e2d6e48"> <div class="panel-body"> <ul type="disc"> <li> <h4><a href="http://www.fda.gov/regulatoryinformation/guidances/default.htm">Search All Guidance Documents</a></h4> Collection of guidance documents that represent the FDA's current thinking on topics.</li> <li> <h4><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="ed951866-3218-4a1b-87a8-968f4e7c4b57" href="/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/inspection-guides" title="Inspection Guides">Inspection Guides</a></h4> 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.</li> <li> <h4><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="c112d0d0-b982-4cc4-941c-c3e28ce9c749" href="/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/foreign-inspections" title="Foreign Inspections">Foreign Inspections - 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It aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.</li> <li> <h4><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="9695b9e8-14a1-4f3b-bbe3-a116b906d7b2" href="/food/foodborne-pathogens/bad-bug-book-second-edition" title="Bad Bug Book (Second Edition)">Bad Bug Book (Second Edition) - Foodborne Pathogenic Microorganisms and Natural Toxins Handbook</a></h4> Provides current information about the major known agents that cause foodborne illness.</li> <li> <h4><a href="/drugs/biosimilars/purple-book-lists-licensed-biological-products-reference-product-exclusivity-and-biosimilarity-or">Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations</a></h4> Lists biological products, including any biosimilar and interchangeable biological products, licensed by FDA under the Public Health Service Act (the PHS Act).</li> <li> <h4><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="41aa2346-1c33-4025-b0c6-e0db744ee4ab" href="/about-fda/reports-manuals-forms/forms" title="Forms">FDA Forms</a></h4> All forms used by the FDA in PDF format.</li> <li> <h4><a href="http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/default.htm">Medical Device GMP Reference Information</a></h4> CDRH page with information on Good Manufacturing Practices (GMP) for medical devices.</li> <li> <h4><a href="/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book">Approved Drug Products with Therapeutic Equivalence Evalutions (Orange Book)</a></h4> 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.</li> </ul> <p><a href="#top">[back to top]</a></p> </div> </div> </div> <div title="Regulatory Information" open="no" class=" panel panel-default fda-accordion-panel"> <div class="panel-heading" role="tab" id="heading_674512e2d6f84"> <h2 class="panel-title"> <a role="button" class="collapsed" data-toggle="collapse" data-parent href="#674512e2d6f84" aria-controls="674512e2d6f84">Regulatory Information</a> </h2> </div> <div id="674512e2d6f84" class="panel-collapse collapse collapsed" role="tabpanel" aria-labelledby="heading_674512e2d6f84"> <div class="panel-body"> <p><a name="regulatory"></a></p> <p>General History and Information Pertaining to FDA Regulations</p> <ul type="disc"> <li> <h4><a href="http://www.ecfr.gov/cgi-bin/text-idx?SID=e8e2e87d7d16c2a08c08f599ce2cedc0&mc=true&tpl=/ecfrbrowse/Title21/21tab_02.tpl">Electronic Code of Federal Regulations (e-CFR)</a></h4> 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.</li> <li> <h4><a href="/laws-enforced-fda" target>Laws Enforced by FDA</a></h4> Resources about legislation affecting the FDA.</li> <li> <h4><a href="/federal-food-drug-and-cosmetic-act-fdc-act" target>Federal Food, Drug, and Cosmetic Act (FD&C Act)</a></h4> Information on and links to the FD&C Act.</li> <li> <h4><a href="/food-and-drug-administration-safety-and-innovation-act-fdasia" target>Food and Drug Administration Safety and Innovation Act (FDASIA)</a>  </h4> The Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law on July 9, 2012, expands the FDA鈥檚 authorities and strengthens the agency's ability to safeguard and advance public health by: <ul> <li><a href="/food-and-drug-administration-safety-and-innovation-act-fdasia#userfees">Giving the authority to collect user fees</a> from industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biological products;</li> <li><a href="/food-and-drug-administration-safety-and-innovation-act-fdasia#innovation">Promoting innovation</a> to speed patient access to safe and effective products;</li> <li><a href="/food-and-drug-administration-safety-and-innovation-act-fdasia#stakeholder">Increasing stakeholder involvement</a> in FDA processes; 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