On January 21, 2009, President Obama issued the Open Government Initiative. These data sets were created to provide public information regarding the various findings that result from inspections.
The Agency is disclosing findings from these inspections to improve the public’s understanding of how the FDA works to protect the public health, provide the public with a rationale for the Agency’s enforcement actions, and to help inform public and industry decision-making allowing them to make more informed marketplace choices and help to encourage compliance. For these data sets, FDA is specifically disclosing citations observed during inspections conducted 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 citations disclosed are associated with completed and finalized inspections.
Citations data contained in these spreadsheets reflect data pulled from FDA's electronic inspection tools. These tools are used to generate the FDA Form 483 when necessary. Not all FDA Form 483s are generated by these tools as some 483s are manually prepared. In addition, 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.
Questions regarding the Citations Database may be directed by email to FDAInspectionsObservations@fda.hhs.gov.
Inspection Citation Dataset: