FDA puts inspections, court actions online
The U.S. Food and Drug Administration on Thursday said it will disclose more information about inspections and court actions online.
The agency now has a Web portal on its enforcement activities as part of the second phase of its Transparency Initiative. These actions are being taken to make FDA's enforcement and compliance-related activities more accessible, downloadable and searchable online.
The information includes a summary of the most common 'inspectional observations' of objectionable conditions or practices made during inspections and a searchable inspections database that includes the names and addresses of inspected facilities, inspection dates, type of FDA-regulated products involved, and final inspectional classification.
By the end of 2011, FDA will also begin to disclose additional information about evaluations of filers, expand disclosure of untitled letters, and inappropriate situations, and support industry efforts during a food recall to inform consumers of products that are not subject to the recall.
The FDA said access to this enforcement and compliance details will provide the public and regulated industry:
' More information about company practices that may jeopardize public health, as well as about companies that have had satisfactory FDA inspections.
' Information about recall and enforcement activities that will help consumers make decisions about products.
' Information about inspection results, which can be expected to create a greater incentive to bring practices into compliance with the law.
' Information about food products that are not subject to a particular recall, which can help reduce consumer confusion.
FDA Commissioner Margaret A. Hamburg announced the agency's Transparency Initiative in June 2009 in response to the Obama administration's commitment to openness in government. After holding public meetings and inviting written comments, FDA issued a report proposing 21 actions to increase disclosures about agency activities. The latest actions stem directly from that effort and are among the first of the proposals to be implemented, FDA said.