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Cumulative number of regulatory and enforcement actions as a result of significant violations observed during an inspection or surveillance activity for FY (1)
Dictionary: The Family Smoking Prevention and Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act and provided the FDA with several enforcement tools to utilize when regulated industry fails to comply with the law. These tools include: warning letter, civil money penalty, no-tobacco-sale order, import alert, seizure, injunction, and criminal prosecution.
Information is current as of September 30, 2012
Fiscal Year - 2012
| Time | Target | Number |
|---|---|---|
| Oct 2011 | N/A | 2 |
| Nov 2011 | N/A | 3 |
| Dec 2011 | N/A | 3 |
| Jan 2012 | N/A | 3 |
| Feb 2012 | N/A | 4 |
| Mar 2012 | N/A | 6 |
| Apr 2012 | N/A | 8 |
| May 2012 | N/A | 13 |
| Jun 2012 | N/A | 21 |
| Jul 2012 | N/A | 25 |
| Aug 2012 | N/A | 31 |
| Sep 2012 | N/A | 34 |
FY Cumulative Total: 34
Footnotes
- (1) Measure does not include regulatory and enforcement actions for those Retailers undergoing Compliance Check Inspections
Total number of regulatory and enforcement actions as a result of significant violations observed during an inspection or surveillance activity in the month
Fiscal Year - 2012
| Time | Target | Number |
|---|---|---|
| Oct 2011 | N/A | 2 |
| Nov 2011 | N/A | 1 |
| Dec 2011 | N/A | 0 |
| Jan 2012 | N/A | 0 |
| Feb 2012 | N/A | 1 |
| Mar 2012 | N/A | 2 |
| Apr 2012 | N/A | 2 |
| May 2012 | N/A | 5 |
| Jun 2012 | N/A | 8 |
| Jul 2012 | N/A | 4 |
| Aug 2012 | N/A | 6 |
| Sep 2012 | N/A | 3 |
FY 2012 Total: 34
Total number of Warning Letters issued as a result of significant violations observed during an inspection or surveillance activity in the month
Warning Letters will generally be issued to other regulated tobacco product entities (e.g., manufacturers, distributors, importers, and Internet retailers), and generally excludes retailers undergoing compliance check inspections, the first time an inspection or surveillance activity reveals that they are not in compliance with tobacco product requirement. The Warning Letters are available in a searchable database on the agency’s website at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm
Fiscal Year - 2012
| Time | Target | Number |
|---|---|---|
| Oct 2011 | N/A | 2 |
| Nov 2011 | N/A | 1 |
| Dec 2011 | N/A | 0 |
| Jan 2012 | N/A | 0 |
| Feb 2012 | N/A | 1 |
| Mar 2012 | N/A | 2 |
| Apr 2012 | N/A | 2 |
| May 2012 | N/A | 5 |
| Jun 2012 | N/A | 8 |
| Jul 2012 | N/A | 4 |
| Aug 2012 | N/A | 6 |
| Sep 2012 | N/A | 3 |
FY 2012 Total: 34
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.
