Rx-360 Summary of the First FDA Annual Report on the Inspection of Registered Establishm?ents

Section 705 of FDASIA, passed in July 2012, requires that FDA report annually on the inspection of registered establishments and post the information on their web site. 

The reports are due no later than 1 February for the prior fiscal year. 

This is the first of the reports and addresses the inspection activities of CDER, CBER, CVM and CDRH registered establishments in FY 2013. 

The report does not cover establishments that manufacture only excipients because FDA databases do not current include these data. 

Data in the report include
◾ Number of registered establishments
◾ Number of foreign and domestic establishment inspections and
◾ Percentage of the budget used to fund these inspections.
 

To view or download the FDA Report, click here

To view or download the Rx-360 Summary of
the FDA Report, click here