Inspection Classification Database

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data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="col-sm-12 col-md-8 col-md-offset-2"> <h1 class="content-title text-center">Inspection Classification Database</h1> <div class="lcds-toolbar lcds-toolbar--social"> <ul class="lcds-share lcds-share--default"> <li class="lcds-share__item"> <a href="https://www.facebook.com/sharer/sharer.php?u=https://www.fda.gov%2Finspections-compliance-enforcement-and-criminal-investigations%2Finspection-classification-database" class="lcds-share__btn lcds-share--default__btn-facebook js-share" id="fb-share" target="_blank"><span class="fa icon-facebook" aria-hidden="true"></span>Share</a> </li> <li class="lcds-share__item"> <a href="https://x.com/intent/tweet/?text=Inspection%20Classification%20Database&url=https://www.fda.gov%2Finspections-compliance-enforcement-and-criminal-investigations%2Finspection-classification-database" target="_blank" class="lcds-share__btn 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data-entity-type="node" data-entity-uuid="ed0cf2a6-a80d-41fe-9ef2-535f4025bf6b" href="/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/nonclinical-laboratories-inspected-under-good-laboratory-practices" title="Nonclinical Laboratories Inspected under Good Laboratory Practices">Nonclinical Laboratories Inspected under Good Laboratory Practices</a>.</li> <li>The results show final classifications of <a href="/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/inspections-database-frequently-asked-questions#classification" target>No Action Indicated (NAI), Voluntary Action Indicated (VAI), Official Action Indicated (OAI)</a> for each <a href="/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/inspection-project-area-listings" target>project area</a> within an inspection.</li> <li>The Inspections Data Dashboard utilizes its content from FDA compliance and enforcement data that is cleared for public access.</li> </ul> </div> </div> </div> <p>The Food and Drug Administration (FDA) inspects and assesses regulated facilities to determine a firm's compliance with applicable laws and regulations, such as the <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="559edc18-553a-4bfb-bb73-0bf1ad6c37d3" href="/regulatory-information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act" title="Federal Food, Drug, and Cosmetic Act (FD&C Act)">Food, Drug, and Cosmetic Act (FD&C Act)</a> and related Acts. The agency updates an <a href="https://datadashboard.fda.gov/ora/cd/inspections.htm">Inspections Data Dashboard</a> weekly that includes final inspection classifications. </p> <p>FDA discloses a segment of inspection information to help improve the public鈥檚 understanding of how the FDA works to protect the public health. Disclosure of a firm鈥檚 inspection information encourages firm compliance and provides the public with an understanding of the Agency鈥檚 enforcement actions and an ability to make more informed marketplace choices.</p> <p>Some inspection data may not be posted until a final <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="2d68c625-a5d5-44ea-9339-febc80e8c0cb" href="/industry/import-program/actions-enforcement" title="Actions & Enforcement">enforcement action</a> is taken.  Descriptions of posted inspection citations may not necessarily represent citations on the final classification letters.</p> <h2>Inspection Observations</h2> <p>FDA investigators may observe conditions they deem to be objectionable during inspections. These observed conditions or practices are listed on the Form FDA-483 Inspection Observations, Form FDA-4056 Produce Farm Inspection Observations, or notated in the Establishment Inspection Report and indicate that an FDA-regulated product may violate applicable laws and regulations.</p> <p>Inspected firms are encouraged to respond in writing, within 15 days from the issuance of the FDA- 483, FDA-4056, or verbal observations, by submitting their corrective action plan with supporting documentation, and promptly implement corrective actions to address the cited objectionable conditions. The FDA considers all evidence, including collected documentation and firm responses when determining whether to take regulatory action against a firm.</p> <p>The agency assigns inspected firms a final classification that includes:</p> <ul> <li><strong>No Action Indicated (NAI)</strong> classification indicates a facility is in an acceptable state of compliance. The facility, usually, was not issued a Form FDA-483 or FDA-4056 at the conclusion of the inspection.</li> <li><strong>Voluntary Action Indicated (VAI)</strong> classification indicates the inspection found objectionable conditions or practices but the agency has determined the facility can voluntarily correct its deficiencies and will not recommend any action. Usually, the facility was issued a Form FDA- 483 or FDA-4056 at the conclusion of the inspection.</li> <li><strong>Official Action Indicated (OAI)</strong> classification indicates a facility is in an unacceptable state of compliance. The facility may have been issued a Form FDA- 483 or FDA-4056 at the conclusion of the inspection.</li> </ul> <div alt="OII inspections fact sheet - 091224 version" data-embed-button="media_browser" data-entity-embed-display="media_image" data-entity-embed-display-settings="portrait_3_4_112_x_150 Array" data-entity-type="media" data-entity-uuid="9fd612e8-c117-4a7d-b667-ff1951665c5b" data-langcode="en" title="OII inspections fact sheet - 091224 version" class="align-right embedded-entity"> <img loading="lazy" src="/files/styles/portrait_3_4_112_x_150/public/OII%20Inspections%20Fact%20Sheet%20-%20091224.png?itok=r7ayEWOM" alt="OII inspections fact sheet - 091224 version" title="OII inspections fact sheet - 091224 version" class="img-responsive"> </div> <p>FDA鈥檚 final inspection classification is usually sent in a letter to the firm within 45 - 90 days from the close of an inspection, depending on the inspection type. </p> <p><a data-entity-substitution="media_download" data-entity-type="media" data-entity-uuid="b4902ac1-a0ba-41fe-ab7d-9eaca79a3629" href="/media/181859/download?attachment" title="OII inspections fact sheet - 091224 version">Download this infographic</a> to learn more about the FDA Inspectional Process. </p> <h2>Inspection Classification Importance for Consumers</h2> <p>Sharing the FDA鈥檚 inspection information helps the public understand the agency鈥檚 inspection process and efforts to protect the public health. This information helps the public make more informed marketplace choices.</p> <h2>Inspection Classifications Importance for Firms </h2> <p>Inspection information encourages firm compliance with applicable laws and regulations to produce and distribute safe products across the United States. The FDA <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> is available publicly so that regulated industry and other external stakeholders can better understand FDA operations. IOM Chapter 5 describes inspectional activities including:</p> <ul> <li>Inspection Walk-Through</li> <li>Procedures and Techniques</li> <li>Reportable Observations</li> <li>Post-Inspectional Contacts</li> </ul> <p>Whether action is indicated or not after an inspection, the FDA provides the latest information for firms to maintain good manufacturing practices. Regulated small businesses can <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="33cb929b-3c71-4038-b667-7cb2353e3033" href="/industry/small-business-assistance" title="Small Business Assistance">contact the FDA for assistance</a>.</p> <h3>Resources By Commodity</h3> <ul> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="2d4eef52-8a69-4f79-bb9b-ec89d9728e52" href="/animal-veterinary/compliance-enforcement/cvm-compliance-programs" title="CVM Compliance Programs">Animal and Veterinary</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="a02e82d2-907e-444e-a7f9-8d595a4d49e3" href="/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics" title="Guidance, Compliance & Regulatory Information (Biologics)">Biologics</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="ddf94c69-2607-489f-bc79-bdd6d75aad18" href="/food/compliance-enforcement-food/inspections-protect-food-supply" title="Inspections to Protect the Food Supply">Foods</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="b79d581b-5da5-4fee-a1b3-947e97eee795" href="/drugs/guidance-compliance-regulatory-information/pharmaceutical-inspections-and-compliance" title="Pharmaceutical Inspections and Compliance">Human Drugs</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="5aa4cfa6-0075-4f0b-a8e7-2aa1de05aed5" href="/medical-devices/resources-you-medical-devices/industry-medical-devices" title="Industry (Medical Devices)">Medical Devices</a></li> <li><a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="b5c6043a-2e6a-40f8-99b5-35342e649c31" href="/tobacco-products/compliance-enforcement-training" title="Compliance, Enforcement & Training">Tobacco</a></li> </ul> <p>Check out the <a href="https://datadashboard.fda.gov/ora/cd/inspections.htm">Inspections Data Database</a> to review a firm鈥檚 compliance status.</p> <h2>Inspection Classification Database and Search</h2> <p>Please use the <a href="https://datadashboard.fda.gov/ora/cd/inspections.htm">FDA Data Dashboard</a> for Inspection Classification data. </p> <p>To learn more about the Inspection Classification Database, please visit the <a data-entity-substitution="canonical" data-entity-type="node" data-entity-uuid="0df90647-bbfb-4611-868c-8e539c0347e1" href="/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/inspections-database-frequently-asked-questions" title="Inspections Database Frequently Asked Questions">FAQs page</a>.</p> <p>Questions regarding the Inspection Classification Database may be directed by email to <a href="mailto:FDAInspectionsClassifications@fda.hhs.gov">FDAInspectionsClassifications@fda.hhs.gov</a>.</p> <p> </p> <p> </p>   </div> <aside class="col-md-2 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