FDA Unveils Inspections Database - Pharmaceutical Technology

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FDA Unveils Inspections Database

ePT--the Electronic Newsletter of Pharmaceutical Technology

Last week, FDA added a searchable database of inspection data to its website. The database lists the names and addresses of facilities that the agency inspected during fiscal years 2009 and 2010. Users can find inspection dates, the type of FDA-regulated products that the facilities produced, and the agency’s final inspectional classification, which reflects each firm’s compliance status.

FDA made the database available as part of its Transparency Initiative, which is intended to increase public access to information about the agency’s enforcement and compliance-related activities. Disclosing companies’ compliance status is one way that the agency is explaining its enforcement actions to the public. FDA also intends this disclosure to inform public decisions, to provide information about company practices that may threaten public health, to highlight companies that have had satisfactory inspections, and to encourage compliance.

The database is hosted on FDA’s web portal for information about its enforcement activities. The portal also includes a summary of the most common Inspectional Observations of objectionable conditions or practices. By the end of 2011, FDA will begin to disclose information about FDA evaluations of filers, expand disclosure of Untitled Letters, and support industry efforts during food recalls.

In response to President Obama’s emphasis on openness in government, FDA Commissioner Margaret Hamburg launched FDA’s Transparency Initiative in June 2009. After holding public meetings and soliciting written comments, FDA drafted a report proposing 21 actions to increase disclosures about its activities. The database and web portal are among the first of these proposals to be implemented.


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