FDA 483's

FDA 483 Inspections and Citations for Biologics

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This interactive graphical display draws live data US FDA 483 Inspections and Citations for Biologics from the FDA site and is intended only as a compliance awareness aid and to demo the power of MicroSoft’s Power BI. Please click anywhere on the screen – you cannot break it (yes, really!). At the bottom right-hand side of the page, you can click an arrow, it will maximize on your screen.

If you are looking for the graphs on Devices or Drugs only or all 3, click the respective links.

This trending tool of US FDA 483 is specific to the Inspections and Citations for Biologics. It accumulates and pools Biologics data from over the years and provides a useful visual summary of everything. It can allow you to track, for example, that between 2016 and 2017 there was a 33% increase in citations for Production Processes and Controls (SOPs) and a 4% increase in citations for Records and Reports, whereas between 2015 and 2016 there was actually a 34% and 35% reduction in citations for those areas respectively! People relaxing their guard, perhaps? Or it could also possibly be that auditors were more focused on examining Equipment in 2016 – in 2016 during the slight citation slump for SOPs and Records there was a 17% increase in Equipment citations. Still, the analytics tool is pretty useful in that it can give you a sense of what auditors might be focused on in the coming year!

Knowing the problem trends can help you initiate corrective programs prior to things spiraling out of control or getting picked up in an official audit.  PharmOut believes in operating leaner and reacting faster to quality issues – if you have the tools available to spot problems in advance, why would you wait till the end of the year before correcting an adverse trend?

Please contact info@pharmout.net or info@qiksolve.com  / www.qiksolve.com if this tool is not working or you looking for a Continuous Product Quality Review Dashboard.