FDA 483 Inspections and Citations for Devices

US FDA 483 Inspections and Citations for Devices

Full Screen Mode

This is a free interactive graphical display, drawing live data US FDA 483 Inspections and Citations for Devices from the FDA site against the CRF 820, and is intended only as a compliance awareness aid and to demonstrate the usefulness of the tool. Please click anywhere on the screen, we promise that you won’t be able to break it! If you want the display to maximise on your screen, click the arrow at the bottom right-hand side.

If you are looking for the graphs on Biologics, Drugs only or all 3, click the relevant links to go to your page of interest.

Live FDA 483 tracker – turning data into information

This trending tool of US FDA 483 is specific to the Inspections and Citations for Medical Devices. It accumulates and pools Medical Device 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 16% increase in citations for Corrective and Preventative Actions (CAPAs) and an 8% increase in citations for Design Controls, whereas between 2015 and 2016 there was actually a 7% and 18% reduction in citations for those areas respectively! It could also possibly be due to auditors being more focused on examining Subpart A General Provisions in 2016 – in 2016 during the slight citation slump for CAPAs and Design Controls there was a 12% increase in Subpart A General Provision citations. Still, this tool is still 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 [email protected] or [email protected]  / www.qiksolve.com if you are looking for a Continuous Product Quality Review Dashboard.