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<key-projects><projects><title>Follow Up Inspection Effectiveness Projects</title><description></description><dictionary></dictionary><outcome></outcome><accomplishment>In response to several recommendations in the April 2010 Office of Inspector General’s (OIG) report entitled &lt;a href=" http://oig.hhs.gov/oei/reports/oei-02-08-00080.pdf "&gt;"FDA Inspections of Domestic Food Facilities"&lt;/a&gt;, the Office of Regulatory Affairs (ORA) committed to implementing changes for taking appropriate and timely actions in ensuring compliance and corrections to violations at establishments that have an Official Action Indicated (OAI) inspection classification at the most recent inspection, a Class I recall, and/or those under a consent decree of permanent injunction.  An assessment was conducted to compare and summarize the number of these types of inspections and the status of follow-up inspections.  In August 2011, the Office of Enforcement (OE) in ORA began providing FDA District Offices with monthly status reports listing outstanding domestic inspections (since October 1, 2010) for OAI classifications at the most recent inspection, Class I recall, and consent decrees of permanent injunction.  During the first four months of providing these reports, 3 of 19 District Offices showed an improvement in timely follow-up to OAI inspections as evidenced by a decreasing trend in the number of OAI inspections with outstanding follow-up greater than 6 months.  FDA will continue to monitor and work to improve the timeliness of these follow-up inspections.</accomplishment><accomplishment>The Agency discloses inspection information to help improve the public’s understanding of how the FDA works to protect the public health. Disclosure of the compliance status of firms helps to provide the public and industry with a rationale for the Agency’s enforcement actions, informs market place decision-making, and encourages compliance. FDA inspections and classifications may be publicly searched online at &lt;a href="http://www.fda.gov/iceci/enforcementactions/ucm222557.htm"&gt;www.fda.gov/iceci/enforcementactions/ucm222557&lt;/a&gt;.</accomplishment><accomplishment>FDA's Enforcement Activities: &lt;a href=" http://www.fda.gov/ICECI/EnforcementActions/default.htm "&gt;www.fda.gov/ICECI/EnforcementActions/default.htm &lt;/a&gt; </accomplishment><free-text>A. Improvements in Class I recall follow-up inspection process</free-text><table><title></title><free-text-table></free-text-table><overall-status><briefing></briefing><prior-briefing></prior-briefing></overall-status><row><type></type><milestone-description>1. Expand Inspection Basis Field Choice in FACTS to identify all recall follow-up inspections</milestone-description><milestone-date>10/1/2010</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>9/15/2010</milestone-completion-date></row><row><type></type><milestone-description>2. Compare and summarize all recalling firms with 24-hour Alerts in RES to all recall related follow-up inspections identified in FACTS over a period of 4 months</milestone-description><milestone-date>3/15/2011</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>3/15/2011</milestone-completion-date></row><row><type></type><milestone-description>3. Establish and implement timeframes for follow-up inspections related to Class I Recalls</milestone-description><milestone-date>6/1/2011</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>8/31/2011</milestone-completion-date></row><row><type></type><milestone-description>4. Provide all outstanding follow-up inspections for Class I recalls to ORA Districts each month</milestone-description><milestone-date>7/1/2011</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>7/7/2011</milestone-completion-date></row><footnotes><note></note></footnotes></table><title></title><description></description><dictionary></dictionary><outcome></outcome><accomplishment></accomplishment><free-text></free-text><table><title></title><free-text-table>B. Improvements in outstanding injunctions follow-up inspection process</free-text-table><overall-status><briefing></briefing><prior-briefing></prior-briefing></overall-status><row><type></type><milestone-description>1. Expand Inspection Basis Field Choice in FACTS to identify all injunction follow-up inspections</milestone-description><milestone-date>10/1/2010</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>9/15/2010</milestone-completion-date></row><row><type></type><milestone-description>2. Compare and summarize all firms currently enjoined to all injunction related follow-up inspections identified in FACTS over a period of 4 months</milestone-description><milestone-date>3/15/2011</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>3/15/2011</milestone-completion-date></row><row><type></type><milestone-description>3. Establish and implement timeframes for follow-up inspections related to Injunctions</milestone-description><milestone-date>6/1/2011</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>6/1/2011</milestone-completion-date></row><row><type></type><milestone-description>4. Provide all outstanding follow-up inspections for open Injunctions to ORA Districts each month</milestone-description><milestone-date>7/1/2011</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>7/7/2011</milestone-completion-date></row><footnotes><note></note></footnotes></table><title></title><description></description><dictionary></dictionary><outcome></outcome><accomplishment></accomplishment><free-text></free-text><table><title></title><free-text-table>C. Improvements in Official Action Indicated (OAI) follow-up inspection process</free-text-table><overall-status><briefing></briefing><prior-briefing></prior-briefing></overall-status><row><type></type><milestone-description>1. Expand Inspection Basis Field Choice in FACTS to identify all OAI follow-up inspections</milestone-description><milestone-date>10/1/2010</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>9/15/2010</milestone-completion-date></row><row><type></type><milestone-description>2. Compare and summarize all firms last inspection classified as OAI to all OAI related follow-up inspections identified in FACTS over a period of 4 months</milestone-description><milestone-date>3/15/2011</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>3/15/2011</milestone-completion-date></row><row><type></type><milestone-description>3. Establish and implement timeframes for follow-up inspections related to OAI classifications</milestone-description><milestone-date>6/1/2011</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>8/31/2011</milestone-completion-date></row><row><type></type><milestone-description>4. Provide all outstanding follow-up inspections for previous OAI inspections to ORA Districts each month</milestone-description><milestone-date>7/1/2011</milestone-date><milestone-status>Completed</milestone-status><milestone-completion-date>7/7/2011</milestone-completion-date></row><footnotes><note></note></footnotes></table></projects><related-links><link><url>http://www.fda.gov/AboutFDA/Transparency/track/ucm204013.htm</url><text>FDA-TRACK ORA Dashboard</text></link></related-links></key-projects>਍††਍਍਍਍਍਍਍