FDA inspection – 483 citation tracking

Wireless Sensors in a GMP Environment

FDA inspection – 483 citation tracking

FDA Citation Tracking Tool Updated December 2020

I’m excited to share that QikSolve has a new tool to track and trend all FDA inspection and 483 citations from 2008 to 2015, 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 2015, there were 12060 US Inspections and 4485 International Inspections.

FDA Inspection 483 citations

A click of a mouse gives you a rest of the world view, I can tell you, according to the FDA South Africa was a safe place to buy drugs in 2015!

Rest of world

However of most interest is the 483’s issued from 2006 to 2015 for Drugs, Devices and Biologics, the tools tracks and trends close to 54,000 individual citations by the FDA during this period.

FDA 483 trends per year

Quickly drilling down you can see the actual citations, arranged by sub part of the FDA CFR 211, and trends year on year.

FDA 483 per CFR subpart

Using one of these drill down options, the second highest citation, after “general requirement”, was “Design and Construction features” up 85% year on year, and on top of a trend of 111%, 21%, arguably indicating a trend.

FDA 483 per CFR211.46

This tool can be packaged up with your branding and deployed on your intranet within an hour, leaving QikSolve with the headache of managing the 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 here and here.

Leave a Reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.