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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Inspections Citations

On January 21, 2009, President Obama issued the Open Government Initiative. These data sets were created to provide public information regarding the various findings from inspections conducted from FY 2006 – FY 2012.
 
The Agency is disclosing findings from these inspections to improve the public’s understanding of how the FDA works to protect the public health. Disclosure of reporting citations provide the public with a rationale for the Agency’s enforcement actions and will also help to 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 for 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 which have been finalized and captured in FDA’s electronic system.
 
Inspections listed in this database indicate the reported citation(s) issued for an establishment. FDA is disclosing the citation database to enhance, improve and expand the information available to the public overall and those seeking FOIA records.
 
Citations data contained in these spreadsheets reflect data pulled from FDA's Turbo Establishment Inspection Report (EIR) system. Turbo EIR is FDA's automated Form 483 reporting system. Turbo EIR is utilized to generate the FDA Form 483 when applicable cite modules exist. Not all FDA Form 483s are generated in Turbo EIR as some 483s are manually prepared and not available in this format. In addition, in the event that changes were made to the FDA Form 483 subsequent to uploading into Turbo, the results may not fully reflect the actual final Form 483 copy provided to the firm.
 
Questions regarding the Citations Database may be directed by email to wmail@oc.fda.gov.

 

Inspections Citations Datasets:

 Fiscal Year (FY)Excel format (.xls)Comma-Separated Values format (.csv)
 FY 2012 FY 2012 Inspections Citations FY 2012 Inspections Citations
 FY 2011 FY 2011 Inspections Citations FY 2011 Inspections Citations
 FY 2010 FY 2010 Inspections Citations FY 2010 Inspections Citations
 FY 2009 FY 2009 Inspections Citations FY 2009 Inspections Citations
 FY 2008 FY 2008 Inspections Citations FY 2008 Inspections Citations
 FY 2007 FY 2007 Inspections Citations FY 2007 Inspections Citations
 FY 2006 FY 2006 Inspections Citations FY 2006 Inspections Citations