About FDA
Average number of business days for CVM to complete the review of warning letters from ORA districts and number of OSC staff reviewing warning letters during the month
Dictionary: CVM’s warning letter review ensures that the issued warning letter clearly follows the Agency’s rules, regulations and policies for the animal food/drug/device/biologics regulated industry and that these rules, regulations and policies are being implemented equally across all of the ORA district’s and internationally. Warning Letters are the Agency’s principal means of notifying the regulated industry of violations and achieving prompt voluntary correction. Warning letters need be issued soon after an inspection so the regulated industry is notified of their non-compliance. The regulated industry can then quickly implement corrective actions in order to become compliant with FDA’s rules, regulations and policies.
Information is current as of February 28, 2013.
Fiscal Year - 2013
| Time | Fiscal Year Target | Number |
|---|---|---|
| Oct 2012 | N/A | 34 |
| Nov 2012 | N/A | 19 |
| Dec 2012 | N/A | 20 |
| Jan 2013 | N/A | 25 |
| Feb 2013 | N/A | 37 |
| 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: 27
Number of OSC full time employees reviewing warning letters at the end of the month
Fiscal Year - 2013
| Time | Fiscal Year Target | Number |
|---|---|---|
| Oct 2012 | N/A | 4 |
| Nov 2012 | N/A | 4 |
| Dec 2012 | N/A | 4 |
| Jan 2013 | N/A | 4 |
| Feb 2013 | N/A | 4 |
| 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: 4
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.
