Home > Transparency Posts > New sources of FDA enforcement information posted

New sources of FDA enforcement information posted

Today, the FDA is implementing the first in a series of proposals to increase public understanding of the public health impact of FDA’s enforcement efforts, help inform companies’ efforts to comply with FDA requirements, increase company accountability to consumers and business partners, and help consumers make more informed decisions about the products they buy.

This action stems directly from the FDA Transparency Initiative, which Commissioner Margaret A. Hamburg, M.D. launched in 2009. The initiative is designed to examine all agency activities and consider ways to make them more transparent. After holding public meetings and inviting written comments, FDA issued its first report, proposing 21 actions to increase disclosures about agency activities.  Today, the agency is taking several steps to increase transparency related to its enforcement activities:

• Posting a summary of the most common inspectional observations of objectionable conditions or practices that are made during inspections.

• Providing a searchable database that includes the name and address of inspected facilities, the date(s) of inspection, type of FDA-regulated products involved, and final inspectional classification.

• Alerting the public in a consistent manner about enforcement actions, by issuing press at the beginning and the end of the process, unless confidentiality is necessary.

The FDA is also providing a new web page to house all of the agency’s key transparency activities related to enforcement so that these resources will be easier to find and use.

In the coming months, 3 additional enforcement-related transparency actions will be implemented. FDA will begin to disclose additional information about FDA evaluations of importers, expand disclosure of Untitled Letters, and in appropriate situations, support industry efforts during a food recall to inform consumers of products that are not subject to the recall. FDA will also move forward on other proposals in the report.

Ann Witt
Transparency Coordinator

  1. May 29, 2011 at 11:30 am

    This seems like a positive evolution towards a safer future for all of our families. I hope this one gets through.

  2. June 30, 2011 at 6:56 pm

    Looks good but lets see how it works in practice.

  3. July 4, 2011 at 7:33 am

    great, maybe positive evolution for every body, will see it!

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  4. July 10, 2011 at 2:25 pm

    Sure thing, it is quite nice to know that something is being done, but unless we have some clear results it all remains a beautiful idea. However I have confidence that changes will occur.

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  5. July 13, 2011 at 8:44 pm

    Yes i agree. But, as David say first lets see how it works in practice.

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  6. July 28, 2011 at 5:56 pm

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  7. August 1, 2011 at 11:53 pm

    I have been involved in self help and self healing projects for many years. It always amazed me how many people were distrustful of the government role in health and medicine. I think any and all steps to transparency are great. Food, supplements and medicines, as well as, devices now come from all over the world. It is absolutely necessary to have a group of professionals looking after the quality and use of all this. Transparency only helps to make it more responsive to the needs of the people it serves. I hope it exceeds everyone expectations so we can all heal faster and sleep better.

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  8. August 10, 2011 at 8:41 pm

    I think this is a great first step and keeping things transparent allows for the conscious buyer to make educated decisions that could have long lasting effects on themselves, their families, and the environment.

  9. September 16, 2011 at 9:35 pm

    By doing this FDA is becoming more transparent. And that’s very good news. I really think that this is the right way!

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