Did the pandemic reduce the 483 issuance risk from pre-approval inspections (PAIs)? That is how it appears—especially in Asia—judging by the distribution of recent PAIs and the number of PAIs with only one FDA investigator.
But a deeper look using Redica Systems data shows that the risk of receiving a 483 after a PAI may be even higher than before.
Additionally, the PAI issuance rate is also on par with that of for-cause inspections, according to Redica Systems data (see Figure 1 at the bottom).
[Related: For more on 483 observation trends involving PAIs, view the recording of the webinar, “A Fresh Take on Pre-Approval Inspection Data.”]
A Lower Risk of 483 Issuance?
Since 2017, every region of the globe has seen fewer PAIs, according to our analyses of FDA data. In 2017, 452 PAIs took place. By 2020 and 2021, that number dropped to about 160 inspections each year.
Looking at statistics by region, PAIs have shifted away from the Asia-Pacific region. Only 19% of PAIs took place in Asia in 2021 (and so far in 2022). In 2017, the share was 34% in this region.
PAIs are More Likely to Result in a 483 — Especially in Asia-Pacific
So, does Asia now have a lower 483 issuance rate? Not at all—it is actually much higher than in 2017, going from about 55% to more than 80%.
At that rate, operations in the Asia-Pacific region should expect a 483 to follow a PAI.
But other regions do not have it easy. The world average is up slightly, and the issuance rates for North America and Europe have been relatively flat since 2017 (with Europe seeing a sudden increase this year).
For a visualization of these insights, please refer to the infographic below (click image to enlarge).
You Are Not as Prepared for Your PAI as You Think
When comparing the 483 rate across pre-approval, for-cause, and routine inspections, it becomes apparent that the issuance rate for pre-approval and for-cause inspections is very similar (Figure 1).
The 483 issuance rate for PAIs has increased by 20% since 2017, well above the issuance rate for routine inspections.
Top 3 Issues Found in PAI 483 Observations
Over 1,500 PAI observations were analyzed from over 400 483s using Redica Systems (Figure 2). From this data, the top three deficiencies found during PAIs are:
- Inadequate quality unit
- Laboratory controls
Anyone involved in planning for a PAI would be wise to look into these three areas.
The bottom line? The industry is not as prepared for PAIs as it should, considering that PAIs are scheduled in advance, unlike for-cause inspections.
If your team is responsible for inspection preparation for PAIs, especially for sites in the Asia-Pacific region, your chance of receiving a PAI is higher than what you may expect. This is an area that you should address as part of your inspection preparation.
Redica Systems Can Help With PAI Preparation
Using Redica Systems, our customers can avoid getting misled by incomplete data. They get the whole picture of inspection trends—and that’s not all they can see. Redica Systems provides customers of all sizes in FDA-regulated industries (pharma, biotech, medical device, and food and cosmetics) solutions for the following:
- Inspection Preparation
- Vendor Quality
- Regulatory Surveillance
- Workflows & Collaboration
Contact us today to see how we can help you stay on top of PAI and other regulatory enforcement trends.
[Related: For more PAI insights, click here to access the webinar, “A Fresh Take on Pre-Approval Inspection Data.”]
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