United States Food and Drug Administration's Data Dashboard

Inspections

NEW!
  • Dashboard has been integrated with the ORA Unified Logon application. To obtain the credentials necessary to use the API, please submit authorization key requests using the online ORA Unified Logon application.
  • Published 483s data is now available on the Inspections Dashboard and Firm Profiles.

Caveats:

  • Certain information in these datasets may not be presented or may have changed since the posting. The datasets are updated weekly and only include final actions. If you need to present more recent or more complete data for official purposes or have questions about obtaining other data, please contact the Division of Freedom of Information about what materials may be available in electronic reading rooms or inquire about other datasets that would satisfy your needs.
  • Certain records related to inspections listed with final classifications may not be available under FOIA until determined as closed per 21 CFR 20.64(d). The disclosure of inspectional information is not intended to interfere with planned compliance actions, therefore some information may be withheld from posting until such actions are taken.
  • Each entry in the source data reflects the result of an inspected Project Area. Several Project Areas may be inspected during a single inspection. Therefore, the number of classifications may exceed the Inspection count.
  • For more information on drug inspections, please visit CDER’s Drug Quality, Current Good Manufacturing Practice Inspections and Compliance webpage: Pharmaceutical Inspections and Compliance.
  • Under the Mutual Recognition Agreements (MRAs) between FDA and foreign regulatory authorities, FDA can rely upon information from drug inspections conducted by these authorities. Upon receiving these inspection reports, FDA can assess and classify them. Those inspections that are classified are available on this dashboard. For more information on MRAs, please visit Mutual Recognitions Agreement (MRA).
  • FDA does not issue CGMP certificates at the conclusion of an inspection. Instead, this dashboard provides the outcomes, including classification and other details, of a firm’s most recent inspection. FDA issues CGMP Declarations to convey the CGMP status of a facility to foreign regulators, if requested by a drug manufacturer, only for drugs exported from the U.S.
  • FDA prioritizes human drug manufacturing establishments for surveillance inspections on a risk basis. Time between surveillance inspections should not be interpreted as a measure of facility or product quality (i.e., not having been inspected in several years does not mean there should be less confidence in the facility or its products). For further information on how CDER’s Office of Pharmaceutical Quality prioritizes establishments for inspection, please see CDER MAPP 5014.1 (R1), “Understanding CDER’s Risk-Based Site Selection Model.”
  • The Published 483s table only displays 483 reports that have been cleared and published in the CDER FOIA Electronic Reading Room or the ORA FOIA Electronic Reading Room.
  • Inspectional data does not include State contract inspections at this time. State contract inspections will be posted at a later date.
  • Inspections and Citations data are only posted for inspections where all project area classifications are finalized.
  • FDA may release and publish 483s for inspections that are not displayed on the Inspection Dashboard.
  • Not all FDA Form 483s are generated by FDA’s electronic inspection tools as some 483s are manually prepared. Citations for manually-prepared 483s will not appear in the citations data.
  • If changes were made to the FDA Form 483 and not synchronized with the electronic inspection tools, the results will not fully reflect the actual final Form 483 that was provided to the firm.
  • FDA has removed Medical Device Single Audit Program (MDSAP) audit reports, which are conducted by certified third-party auditors and may be considered in lieu of an FDA surveillance inspection, from the FDA Data Dashboard. FDA has determined that MDSAP audits do not meet the criteria for posting on the FDA Data Dashboard.

Important Notes:

Domestic Inspections

Number of Inspections
  • 0

Inspections Details Popup with Inspections-related terminology Help

Select Inspection ID(s) to view corresponding Inspections Citations.


If filters are applied on this page, the ‘Filtered Data’ link below will download the filtered results.

Inspections Citations Details

link to the Code of Federal Regulations (CFR) annual edition, which is the codification of the general and permanent rules published in the Federal RegisterCFR Reference  |  link to the Federal Food, Drug, and Cosmetic Act (FD&C Act), which is a federal law enacted by Congress. It and other federal laws establish the legal framework within which FDA operatesFDCA Reference

If filters are applied on this page, the ‘Filtered Data’ link below will download the filtered results.

Citations data include Form FDA 483 citations and may not necessarily represent citations on final classification letters.

Published 483s

Published 483s are available in the FDA Reading Rooms at CDER FOIA Electronic Reading Room and ORA FOIA Electronic Reading Room.


If filters are applied on this page, the ‘Filtered Data’ link below will download the filtered results.