Redica Responds is an article series where we take common/unique questions from customers and industry events and answer them with our data. Use the following link to look at all previous Redica Responds articles.

How many 483 observations over the past ten years involve cleaning validation?

Cleaning issues, in particular, cleaning validation (steps to ensure that cleaning processes do not leave residue that could contaminate product) is a concern for FDA investigators. In fact, one FDA investigator identified cleaning and cleaning validation issues as a recurring problem at a conference earlier this year

With that in mind, Redica’s actionable intelligence can show how many FDA 483 observations were issued for cleaning validation issues at human drug GMP sites across the world over a ten-year timespan (2012-2022).

Our data shows there were 273 primary observations in this time period.

Cleaning validation 483s
Redica Systems Enforcement Analytics | Cleaning Validation 483s

Interestingly, there were 161 primary observations involving cleaning validation in the prior ten years (2002-2012).

If you are responsible for inspection preparation, ensuring that your cleaning validation is up to snuff might not be a bad idea. And if you are overseeing vendor quality, this is certainly something to consider when you audit your CMOs.

How Redica Can Help You

With Redica, human drug manufacturers can leverage our deeper intelligence about inspection trends and investigator tendencies for thorough inspection preparation. 

With Redica, you can conduct strategic inspection preparation based on current inspection findings at your sites and others and find trends in the data to identify where to focus your attention. You can also conduct tactical inspection preparation using complete FDA investigator profiles, i.e., what do they tend to look for and what do they tend to find?

Contact us today to learn more about how Redica can help you stay on top of your strategic and tactical inspection preparation.

Additional Cleaning and Cleaning Validation Resources

Inadequate Equipment Cleaning Leads to Cross Contamination, FDA Warnings

Many Device Cleaning Validation Programs Need Work, FDA Investigator Says

Cleaning and Cross-contamination Issues with an Encapsulator

Warning Letters Week Of 10/25/2020: Cleaning Validation

Warning Letters Week of 8/30/2020: Adulterated Products

Prevention of Cross-Contamination in the Pharma Industry  

[Related: Learn more about FDA inspection trends involving equipment cleaning and other GMP issues by reading the latest report by Redica Systems Senior GMP Quality Expert Jerry Chapman.]

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