FDA puts enforcement activities online

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The FDA has created a searchable database where users can research the enforcement activities of the agency, including inspection records, as part of its ongoing efforts to increase transparency.

The agency will disclose more information about inspections and court actions as part of Phase II of the agency’s Transparency Initiative, an effort launched by FDA Commissioner Margaret Hamburg, MD, in June 2009 under President Obama’s directive for more public access to federal agencies with broad regulatory and enforcement responsibilities.

The public information now available includes the names and addresses of inspected facilities, inspection dates, the type of FDA-regulated products involved and final inspection classification. It also includes a summary of the most common inspectional observations of objectionable conditions, according to an FDA release.

By the end of this year, the agency said it will disclose additional information, including evaluations of filers and expanded disclosure of untitled letters, according to the release.

The Transparency Initiative is a three-phase effort to provide more public access to the workings of the agency and is overseen by a task force whose goal is to seek public input, recommend ways to better explain the operations of the agency, identify problems and evaluate ways to better communicate with the public, stated the FDA.

Click here to access the database.