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How do repeat observations compare between North America and the Asia-Pacific regions?

Repeat observations are FDA 483 observations from more than one inspection. Receiving repeat observations is likely to lead to further enforcement actions.

When it comes to repeat observations, how do the United States and Canada compare to other regions, such as the Asia-Pacific region? Does one region receive more repeat observations than the other?

Let us take a look!

Within Redica, we ran two reports that take a deep dive into FDA 483 observations. In this case, we generated a report showing the number of human drug GMP 483 observations for the period of 2007-2022 (a 15-year time frame). 

We ran the same report for both North America (the United States and Canada) and the Asia-Pacific region.

Within the 15-year period, there were eight 483 repeat observations at North American facilities and nine for facilities in the Asia-Pacific region. So, pretty much on par for each region.

Repeat Observations by Region
Redica Systems Enforcement Analytics | Repeat Observations

We also ran the same report for Europe and there were no 483 repeat observations for that region in the selected time frame.

How Redica Can Help You

With Redica’s actionable intelligence, you can unlock insights that help you better prepare for your next inspection. Our Enforcement Analytics enables you to base your audits and inspection planning activity on the most comprehensive and up-to-date inspection and enforcement trends benchmarked to the industry.

Contact us today to learn more about how we can help you stay on top of the latest inspection trends involving contamination and other issues.

Additional Resources

The FDA Inspection is Over, What Happens Next?

Can a Robust QMS Lead to Reduction of 483 Observations?

FDA Warning Letters Week of 2/2/2020: Device Repeat Deficiencies

Repeat Deficiencies in Lupin Limited Warning Letters

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