FDA goes public with enforcement actions
pharmafile | June 2, 2011 | News story | Manufacturing and Production | FDA, transparency
The FDA is to publish more details about inspections and court actions on its website as part of a drive towards greater openness.
A web portal and database has been set up to make the FDA enforcement and compliance-related activities “more accessible, downloadable, and searchable online”, said the agency.
The move stems from the FDA Transparency Initiative – set up in 2009 – and comes shortly after President Obama’s direction to federal enforcement agencies to improve public access to information about their activities, made earlier this year.
The FDA says it will provide more information about company practices that may jeopardise public health and help consumers make decisions about products based on recall and enforcement activities.
Shining a light on inspection results will also help “to create a greater incentive to bring practices into compliance with the law”, it added.
The database includes the name and address of inspected facilities, the dates of inspection, the type of FDA-regulated products involved, and the outcome of the inspection, as well as summaries of the most common observations noted.
For example, in 2010 the three most common issues noted in inspections of drug facilities were the lack of clear, written quality control procedures, failure to follow standard operating procedures (SOPs) and failure to investigate batch failures.
By the end of the year, the FDA will also begin to disclose additional information about ‘Untitled Letters’, which are an initial correspondence with a company citing violations that do not meet the threshold of regulatory significance for a full-blown warning letter.
Phil Taylor
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