Data Range: FY 2009 - FY 2016
For definitions of terms and data elements see the Glossary
- Inspections and related data disclosed only include completed and finalized inspections of clinical trial investigators, Institutional Review Boards (IRB), and facilities that manufacture, process, pack, or hold an FDA-regulated product that is currently marketed.
- 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.
- Please visit the Inspection Database for the most recent inspectional information.
- Inspectional data does not include State contract inspections at this time. State contract inspections will be posted at a later date.
Certain information in these datasets may not be presented or may have changed since the posting. The datasets are updated semi-annually 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.