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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 - 2013
| Time | Target | Number |
|---|---|---|
| Oct 2012 | N/A | 6 |
| Nov 2012 | N/A | 16 |
| Dec 2012 | N/A | TBD |
| Jan 2013 | N/A | TBD |
| Feb 2013 | N/A | TBD |
| Mar 2013 | N/A | TBD |
| Apr 2013 | N/A | TBD |
| May 2013 | N/A | TBD |
| Jun 2013 | N/A | TBD |
| Jul 2013 | N/A | TBD |
| Aug 2013 | N/A | TBD |
| Sep 2013 | N/A | TBD |
FY 2013 YTD: 16
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 - 2013
| Time | Target | Number |
|---|---|---|
| Oct 2012 | N/A | 6 |
| Nov 2012 | N/A | 10 |
| Dec 2012 | N/A | TBD |
| Jan 2013 | N/A | TBD |
| Feb 2013 | N/A | TBD |
| Mar 2013 | N/A | TBD |
| Apr 2013 | N/A | TBD |
| May 2013 | N/A | TBD |
| Jun 2013 | N/A | TBD |
| Jul 2013 | N/A | TBD |
| Aug 2013 | N/A | TBD |
| Sep 2013 | N/A | TBD |
FY 2013 YTD: 16
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 - 2013
| Time | Target | Number |
|---|---|---|
| Oct 2012 | N/A | 6 |
| Nov 2012 | N/A | 4 |
| Dec 2012 | N/A | TBD |
| Jan 2013 | N/A | TBD |
| Feb 2013 | N/A | TBD |
| Mar 2013 | N/A | TBD |
| Apr 2013 | N/A | TBD |
| May 2013 | N/A | TBD |
| Jun 2013 | N/A | TBD |
| Jul 2013 | N/A | TBD |
| Aug 2013 | N/A | TBD |
| Sep 2013 | N/A | TBD |
FY 2013 YTD: 10
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.
