CDER inspections in the Asia Pacific region are up 103% since 2013. How has that influenced enforcement actions? And what about your supply chain?

In this article, we present the data and trends of CDER enforcement in the Asia Pacific region from 2013 through 2018. We will look at:

  • Number of inspections year-over-year
  • 483 issuance rate* trends
  • Warning letter issuance rate trends

*For issuance rate metrics we use the date of inspection, not the warning letter issuance date.

Some of the questions we answer here include:

  • What Asia Pacific countries receive the most inspections?
  • Which countries receive the most warning letters?
  • How does Asia Pacific compare to CDER averages by region?

[NOTE: Continue reading to find out the answers to these questions, or check out our graphic presentation of this post in an easy-to-share slide format. Download it here.]

Is FDA focusing on Asia Pacific?

As indicated in the CDER Manual of Policies and Procedures (MAPP), FDA will focus their efforts and inspections according to outlined risk factors and site scoring methods. (For an in-depth review of FDA’s ongoing efforts at transparency in the CDER GMP inspection process, read our two-part series Criteria for Drug Inspections.)

So, does it seem that the Asia Pacific region is a focus for FDA enforcement?

As seen in Figure 1, the number of inspections in Asia Pacific (further referred to as APAC) doubled from 2013 to 2018.

Compared to the two other most-inspected regions, North America and Western Europe, the compound annual growth rate (CAGR) of APAC inspections is considerably higher at 15.3%. The region with the second highest CAGR is Western Europe at just 2.9%.

What countries received the most inspections?

Seen in Figure 2, India consistently received roughly half of all APAC inspections every year since 2013. China received an average 26.8% of inspections within the same time frame. We at Govzilla expect these numbers to grow.

Perhaps most notably though, inspections in South Korea have skyrocketed in the last two years causing a 580% growth rate since 2013, and inspections in Japan have also increased significantly for a 289% increase rate since 2013.

Is APAC 483 issuance rate increasing?

Based on the significant increase of inspections in the region, has APAC received more 483s?  

The answer, perhaps surprisingly, is no.

As seen in Figure 3, roughly half of all CDER inspections result in 483 issuances. Although APAC issuance rate (percentage of inspections receiving a 483) does not correlate with increased inspections, it should be noted that this rate averages about 10% higher than the CDER average throughout the past six years.

How has APAC warning letter issuance rate changed?

Considering that inspections have increased and 483 issuance rate has remained consistent, what could we expect for warning letter issuance?

The CDER average over the last five years for inspections resulting in a warning letter is 3.8%. As seen in Figure 4, while the issuance rates of every other region were below the CDER average in 2017, warning letter issuance in APAC nearly doubled from 2016 to 2017 for a 4.7% difference higher than the CDER average.

What APAC countries are receiving these warning letters?

Since India and China receive the most inspections in this region, should we assume they also receive the most warning letters?

We break down the percentages of APAC warning letter issuance by country in Figure 5.

Despite that India receives roughly half of all APAC inspections, it’s warning letter issuance rate in 2017 is right at the CDER average with 3.9%, and it’s even lower in 2015. Also interesting is that Japan had a higher warning letter issuance rate than India in both 2016 and 2017.

The leaders in APAC warning letter issuance as of 2017 are China and South Korea. Both show almost a 10% increase from just the year prior to 15.6% and 14.3% respectively. As well as both having nearly double the percentage of the APAC average in 2017, they are, respectively, 122% and 116% higher than the overall CDER average.

Conclusions

So what are the main takeaways of APAC enforcement trends?

  • APAC warning letter issuance doubled from 2016 to 2017.
  • APAC inspections are up 103% since 2013. The FDA is clearly focused on conducting more inspections in APAC. If you have suppliers or CMOs in this region and have not had an inspection recently, you may want to be inspection-ready.
  • 483 issuance rate in APAC is not necessarily getting better or worse. For the past six years, this rate floats an average of 10% higher than the CDER average. We expect this to continue.
  • China and South Korea lead the way in APAC warning letter issuance.

[NOTE: Like this post? Download the graphical presentation here.]

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