Data Integrity Trends in 483s and Warning Letters: Part 3

This is the last part in a series of three posts; get up to speed with parts one and two.

Now that we’ve reviewed top-level data integrity (DI) trends and what DI keywords the FDA is citing in 483 Observations, let’s look at DI keywords cited in warning letters.

(NOTE: Looking for an easier way to research observations by specific keyword?  Get your FREE 483 Observation Report and you can quickly determine who has been hit with the same observations. Learn more here!)


Does the FDA cite the same DI keywords on warning letters as 483s?

Simple answer = not really!

Figure 1 compares the top cited keywords on 483s to those in Warning Letters.  Interestingly, “data integrity” is the 33rd most popular term in 483s citing DI, but it is the #2 term on Warning Letters.  In other words, when the FDA cites DI on 483s, they hardly ever actually say “data integrity” and they almost never mention their favorite DI acronym “ALCOA”.


How do ALCOA Plus categories compare between 483s and Warning Letters?

Figure 2 breaks down the topic mentions in 483s compared to warning letters. The structures and purposes of the 483 and warning letter may dictate some of these differences.  Here are our top takeaways:

  1. The verbiage is more concise in warning letters than 483s and therefore likely indicates the decrease in certain keyword mentions.
  2. Data destruction, manipulation, and unauthorized access are far more prevalent in Warning Letters.
  3. The FDA actually says “ Data Integrity” on Warning Letters – it is 500% more likely to be specifically mentioned.


Overall Conclusions

So what can we take away from FDA’s enforcement on data integrity?

  • Data integrity is a vast category encompassing 200+ keywords and phrases to be attributed and researched; mapping these keywords onto the ALCOA Plus categories provides better understanding.
  • FDA clearly has a focus on this area with about 80% of CDER warning letters citing data integrity keywords.
  • Regardless of company size, roughly 50% of all CDER 483s cite data integrity concerns.
  • Asia gets the highest percentage of DI citations, Europe the fewest.
  • “Accurate” is one of the most-cited DI keywords in 483s and warning letters, while “Data Integrity” is 500% more likely to be cited on warning letters.

What else would you like to see?  Please leave us a comment below.

(NOTE: Did you know you can easily search observations by keywords such as data integrity, process validation, complaints and more?  Get your FREE 483 Observation Report and you can quickly determine who has been hit with the same observations. Learn more here!)



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