FDA Launches Enforcement, Compliance Web Portal

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.

The U.S. Food and Drug Administration announced 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. 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 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 FDA hopes 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 Dr. Margaret A. Hamburg launched FDA’s Transparency Initiative in June 2009. After holding public meetings and inviting written comments, FDA issued a report proposing 21 actions to increase disclosures about agency activities. The actions announced today stem directly from that effort and are among the first of the proposals to be implemented.

For more information, go to FDA’s Inspections Database.

Download Center

HTML - No Current Item Deck
  • Free Safety Management Software Demo

    IndustrySafe Safety Management Software helps organizations to improve safety by providing a comprehensive toolset of software modules to help businesses identify trouble spots; reduce claims, lost days, OSHA fines; and more.

  • Easy to Use Safety Incident App

    Record incidents on the go with IndustrySafe’s mobile app. Collect data for multiple types of incidents including including near misses, vehicle and environmental incidents, and employee and non-employee injuries; at job sites and remote locations—with or without web access.

  • Complete Online Safety Training Courses

    Deliver state-of-the art, online safety training courses to your organization with IndustrySafe Training Management Software. Generate reports to track training compliance and automatically notify learners of upcoming or overdue classes.

  • Conduct EHS Inspections and Audits

    Record and manage your organization’s inspection data with IndustrySafe’s Inspections module. IndustrySafe’s pre-built forms and checklists may be used as is, or can be customized to better suit the needs of your organization.

  • Track Key Safety Performance Indicators

    IndustrySafe’s Dashboard Module allows organizations to easily track safety KPIs and metrics. Gain increased visibility into your business’ operations and safety data.

  • Industry Safe
comments powered by Disqus