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Archive for May, 2011

New sources of FDA enforcement information posted

May 26, 2011 28 comments

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

Upcoming Event: FDA Basics Webinar on Foreign Inspections, May 17, 2011, at 12:30pm ET

May 12, 2011 25 comments

Did you know that FDA foreign inspections have doubled since 2008? Did you know that foreign food inspections alone have quadrupled since 2010?

As part of FDA Basics, FDA is hosting a webinar on foreign inspections where you can learn more. Susan Laska, the Deputy Director of the Division of Foreign Field Investigations, will give an overview and answer questions about FDA’s Global Inspection program.

The free 30 minute webinar will be held Tuesday May 17, 2011 at 12:30 pm ET.

There are a limited number of spots available for the webinar. Materials from the webinar will also be made available on the FDA website following the presentation.

Learn more about the webinar, including instructions about how to join the webinar.

Ann Witt, Transparency Initiative Coordinator

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