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U.S. Department of Health and Human Services

About FDA

Follow Up Inspection Effectiveness Projects

Accomplishment: In response to several recommendations in the April 2010 Office of Inspector General’s (OIG) report entitled "FDA Inspections of Domestic Food Facilities", 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.

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 www.fda.gov/iceci/enforcementactions/ucm222557.

FDA's Enforcement Activities: www.fda.gov/ICECI/EnforcementActions/default.htm

A. Improvements in Class I recall follow-up inspection process

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Expand Inspection Basis Field Choice in FACTS to identify all recall follow-up inspections

10/1/2010

Completed 9/15/2010

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

3/15/2011

Completed 3/15/2011

3. Establish and implement timeframes for follow-up inspections related to Class I Recalls

6/1/2011

Completed 8/31/2011

4. Provide all outstanding follow-up inspections for Class I recalls to ORA Districts each month

7/1/2011

Completed 7/7/2011

B. Improvements in outstanding injunctions follow-up inspection process

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Expand Inspection Basis Field Choice in FACTS to identify all injunction follow-up inspections

10/1/2010

Completed 9/15/2010

2. Compare and summarize all firms currently enjoined to all injunction related follow-up inspections identified in FACTS over a period of 4 months

3/15/2011

Completed 3/15/2011

3. Establish and implement timeframes for follow-up inspections related to Injunctions

6/1/2011

Completed 6/1/2011

4. Provide all outstanding follow-up inspections for open Injunctions to ORA Districts each month

7/1/2011

Completed 7/7/2011

C. Improvements in Official Action Indicated (OAI) follow-up inspection process

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Expand Inspection Basis Field Choice in FACTS to identify all OAI follow-up inspections

10/1/2010

Completed 9/15/2010

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

3/15/2011

Completed 3/15/2011

3. Establish and implement timeframes for follow-up inspections related to OAI classifications

6/1/2011

Completed 8/31/2011

4. Provide all outstanding follow-up inspections for previous OAI inspections to ORA Districts each month

7/1/2011

Completed 7/7/2011

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.