I’m excited to share that QikSolve has helped us to update track and trend all the FDA inspection 483 citations from 2011 to current months. This 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, impacting the pharmaceutical, medical devices and biologics industry.
An example is the 10 year inspection trends for devices, drugs and biologics, shown below, which was exported from the QikSolve tool (2014 to 2024).
Image 1 – 10 year comparison of FDA inspections per category
If you looking for the trends or graphs on Biologics, Devices or Drugs only, click the respective links.
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 (where, for example, you can see the inspection trends by years.
Image 2 – Expanded to country selection view
The value of being able to visualise inspection data and FDA 483 citations
In addition to being able to detect shifts in the focus of FDA inspectors and improve your systems before your next inspection, this data is a powerful tool for understanding the industry from a global perspective.
For example, In 2020, 2021 and 2022 (during the travel-restricted years of the pandemic) the number of inspections was radically decreased, particularly international inspections. In recent years, the number of inspections still remain lower than pre-pandemic levels, as clearly depicted in Image 1 above.
Image: (c) PharmOut Pty Ltd and QikSolve
Image 3 – Exploring FDA 483 citations by a specific country (international FDA inspections data)
FDA 483 citations international
Example: FDA 483 citations international South Africa
Most interesting in the historical data for FDA inspections and 483 citations in South Africa were the 483’s issued from 2006 to 2022 for Drugs, Devices and Biologics.
The tracking tool revealed close to 98,000 individual citations by the FDA in South Africa during that period.
483 issued during all FDA inspections (15 year view – historical data).
Of course, it is better to look at the data yourself. To have a play with the data, follow this link to the site with all 3 sets of data, where 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.
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
Looking at 10 year trends for Biologics inspections and citations, for example, would give you the following display:
Summary
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.
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.
Obviously PharmOut can offer GMP compliance consulting advice on how this deployment should be performed.
You are welcome to copy 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.
Please complete the form on the PharmOut contact us page. We will get back to you within one business day. Phone: +61 3 9887 6412 Email: info@pharmout.net
