FDA inspection – 483 citation tracking

FDA Citation Tracking Tool Updated October 2022

I’m excited to share that QikSolve has helped us to update track and trend all the FDA inspection 483 citations from 20011 to 2021, the tool dynamically scrapes data from various live websites and databases and provides a single, secure portal which to track and trend data, or rather to visualise data.

If you looking for the trends or graphs on Biologics, Devices or Drugs only, click the respective links.

This technology platform / tool is already being used by many QikSolve clients to provide management dashboards, i.e. like continuous product quality reviews. PharmOut is proud to be associated with this innovative company which is leading thinking on developing emerging technologies and maximizing client value. PharmOut provides GMP compliance and Computer Systems Validation support.  The core technology platform is the trusted Microsoft, Office 365 and SharePoint, once the Office 365 is purchased, the platform comes free of charge.

Obviously PharmOut can advise on offering advise on how this deployment should be performed.

Back to the data, from 2008 to 2022, there were 80,235 US Inspections and only 17,856 International Inspections.

In 2020, 2021 and 2022 the number of inspections has radically decreased, with only 148 international inspections in 2021.

 

A click of a mouse, see below, gives you a rest of the world view, or you can zoom in on a specific country like South Africa, you can see no inspections were done by the US FDA in 2015!

However, of most interest is the 483’s issued from 2006 to 2022 for Drugs, Devices and Biologics, the tools tracks and trends close to 98,000 individual citations by the FDA during this period.

Drilling down, you can see the actual citations and specific CFR clause, arranged by sub part i.e. FDA CFR 606.100(b), and provides trends year on year, in the graphic below, you can see that SOP are a problem in Biological facilities.

FDA 483 by CFR clause biologics

If you are using MicroSoft Office 365, your branding could be added and deployed on your intranet within an hour or two, leaving QikSolve with the headache of managing the FDA site data scraping and connectors.

Of course, it is better to look at the data yourself and please play with the data, follow this link to the site only with all 3 sets of data, you can filter by Biologics, Devices and Drugs.

If you just looking for the trends or graphs on Biologics, Devices or Drugs only follow the respective links. Good luck.

You welcome to pick up the iframe link and insert it to your intranet? The data is dynamically updated as well as upgraded from time to time, if you follow the PharmOut LinkedIn Group, we will let you know when the link is updated.

Read more on similar topics on the updated 483 Citation tool click here.