The U.S. Food and Drug Administration (FDA) announced recently that it is disclosing more information about inspections and court actions, and now has a web portal on its enforcement activities as part of Phase II of the agency’s Transparency Initiative. Now, FDA’s enforcement and compliance-related activities will be more accessible, downloadable, and searchable online.
According to FDA’s press release:
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 FDA evaluations of filers, 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.
Access to this information about FDA’s enforcement and compliance activities will provide the following to 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.
The Transparency Initiative was first launched in June 2009. These most recent actions by FDA represent some of the first of the original proposals to be implemented.