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Compliance In Focus
Posted by John Lehmann on Mon, Jul 2, 2012

New: FDA Enforcement Reports

As a follow-up to the FDA announcement of delivering simple, clear device recall reports to the public,FDA Enforcement Reports the first new format of the document is available! As stated on the FDA website, the format updates to the weekly enforcement report “offers downloadable data for analyses while also providing savings and encouraging future innovation for Government. This data-driven report provides FDA a baseline as it moves forward in its efforts to integrate the Agency’s compliance and enforcement data.”

So, what are some of the improvements in this new Enforcement Report?

  • The top of the report includes tabs which break down the category of recall: biologics, devices, drugs, food/cosmetics, veterinary
  • The columns of the report allow for searchable information regarding: recalling firm, classification, status, distribution patter, and even details
  • The report has icons for printing, emailing, and downloading in csv formatting
  • Also available is an Enforcement Report Navigation and Definitions page

The FDA is also encouraging feedback on the new report, so take a look at this week’s report and let us know what you think!

Photo Credit: kenteegardin

Topics: FDA Enforcement Reports, FDA Website, Device Recall Reports


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