FDA 483 Inspections and Citations for Drugs

US FDA 483 Inspections and Citations for Drugs

Full Screen Mode

This is a free interactive graphical display, drawing live data US FDA 483 Inspections and Citations from the FDA site, and is intended only as a GMP awareness aid and to show the power of the tool. Please click anywhere on the screen – you honestly won’t be able to break it! At the bottom right-hand side of the display, you can click an arrow that will allow it to maximize on your screen.

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

Live FDA 483 tracker – turning data into information

This trending tool of US FDA 483 is specific to the Inspections and Citations for Drugs. It accumulates and pools Pharmaceutical 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 9% increase in citations for Organization and Personnel and an 6% increase in citations for Records and Reports, whereas between 2015 and 2016 there was actually an 8% and 12% reduction in citations for those areas respectively! It could also possibly be due to auditors being more focused on examining Laboratory Controls and Records in 2015 and 2016 but 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 you are looking for a Continuous Product Quality Review Dashboard.