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U.S. Department of Health and Human Services

International Programs

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Compliance Transparency Initiative

 

May 27, 2011

 

Dear International Colleague:

I am writing to inform you that yesterday the U.S. Food and Drug Administration (FDA) announced it will begin implementing the first in a series of proposals to make its inspection and compliance activities more transparent. In response to President Obama's commitment to openness in government, U.S. FDA Commissioner Dr. Margaret Hamburg launched FDA's Transparency Initiative in June 2009. After holding public meetings and inviting written comments, our agency issued a report proposing 21 initiatives to increase public disclosures about our agency's activities. The actions announced yesterday are being taken to make our enforcement- and compliance-related activities more accessible, down-Ioadable, and searchable online.

The information that was taken yesterday is meant to (l) disclose new information about inspections, (2) help inform the public about industry's compliance efforts, (3) increase industry's accountability, and (4) assist consumers in making more informed decisions about the FDA-regulated products they consume or use. The specific activities in our announcement include FDA's efforts to:

  • Post a summary ofthe most common Inspectional Observations of objectionable conditions or practices that are made during inspections; and
  • Provide a searchable database that includes the names and addresses of inspected facilities, the date(s) ofinspection, the type ofFDA-regulated products covered during the inspection, and the final inspectional classification. FDA typically classifies its inspections as No Action Indicated (NAI); Voluntary Action Indicated (VAI), or Official Action Indicated (OAI).

The Inspectional Observations Summary will include objectionable observations noted during all inspections whether they were conducted in the United States or abroad; however, it will not delineate whether those objectionable conditions were observed during a foreign or,a domestic inspection. The summary posted includes inspectional observations made during Fiscal Years 2006 - 2010. A "fiscal year" for U.S. FDA runs from 01 October through 30 September. Thus, "fiscal year 2006" covers inspections conducted between 01 October 2005 and 30 September 2006. We plan on updating this information on an annual basis. The summary of objectionable inspectional observations can be found at:

http://www.fda.gov/ICECI/EnforcementActions/ucm250720.htm

The Inspection Database is searchable and lists both U.S. and non-U.S. facilities at which U.S. FDA conducted inspections in Fiscal Years 2009-2010. Any such inspection results which are still under evaluation, are pre-authorization, or are Good Laboratory Practice inspections have been excluded from the data at this time, but may be considered for inclusion in the future. U.S. FDA presently plans to update this database twice a year.

To view the inspection classification database, go to:

http://www.fda.gov/ICECI/EnforcementActions/ucm222557.htm

I wanted to be sure to let you know about today' s announcement because it is very possible that you may receive inquiries from your stakeholders about the information we have posted, especially ifthe companies are located in your country. It is also possible that you may be asked how your most recent inspection conclusions about these companies compare to our findings. In addition, you may be asked ifyou are aware of our findings and/or what efforts you may have taken in respect to these companies. Lastly, it is possible that you may wish to use this information to inform your own regulatory efforts. I just did not want you blindsided by this action, and not be aware if such questions were asked of you.

We hope that by disclosing objectionable conditions observed during FDA inspections, the public will have a better understanding ofhow we work to protect the public health. Disclosing the compliance status of inspected establishments will also enable the public to have a better understanding of our enforcement actions. Likewise, posting this information may deter future violations and, hopefully, increase the regulated industry's compliance with applicable public health regulations.

In the coming months, additional transparency actions will be implemented and we will continue to move forward with other proposals. More information about our Transparency Initiative, including the report which lists all 21 of FDA's proposed actions, can be found at:

http://www.fda.gov/AboutFDA/Transparency/TransparencyInitiative/default.htm

If you have any questions or concerns about this initiative, please contact me at + 1 301-796-4600 or at Murray.Lumpkin@fda.hhs.gov.

 

Sincerely

---/s/---

Murray M. Lumpkin, M.D., M.Sc.
Deputy Commissioner
International Programs


International Outreach to Foreign Embassies