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What can Redica Systems data tell us about enforcement trends involving media fills? What are the year-by-year numbers?

Media fills are important during the manufacturing of sterile products. Also referred to as “process simulations,” these are used to test whether a manufacturer’s aseptic procedures prevent contamination during production

It goes without saying that if your media fills are inadequate, this could lead to some negative regulatory enforcement actions. 

So, let us see what the data can tell us.

Redica Systems Media Fill Insights

Taking a five-year look back (2017-2021) using Redica Systems, we can see the number of global 483 observations with primary media fills as a primary issue has been stable since 2017, although with a dip beginning in 2020, which is to be expected due to the reduction in onsite inspections during the COVID-19 pandemic.

Figure 1 Number of Media Fill Primary Observations 2017-2021
Redica Systems Enforcement Analytics | Media Fill Primary 483 Observations

But when we look at secondary issues, the numbers per year up to 2020 are much larger–almost four or five times larger than the number of primary 483 observations in the same year.

Number of Secondary Media Fill 483 Observations
Redica Systems Enforcement Analytics | Media Fill Secondary 483 Observations

For a sense of what these issues could be, consider the following case study. A manufacturer of a combination product had to shut down production for a month. Inspectors expect to see a media fill after the shutdown but before manufacturing resumes. In this case, the manufacturer conducted the media fill before the shutdown and then resumed manufacturing without conducting another one.

Additional examples of enforcement actions involving media fills can be found here.

Stay on Top of Enforcement Trends With Redica Systems

Now that onsite inspections have resumed, it is more critical than ever to be aware of regulatory enforcement trends. With Redica Systems, Quality Assurance teams can access deeper intelligence about inspection trends and investigator tendencies

Our inspection intelligence gives you unique insight into every FDA investigator and the latest agency inspection trends across inspection types, including pre-approval inspections (PAIs), for-cause inspections, and routine inspections on all GxPs.

Contact us to learn more about how we can help and to see our capabilities in action.

Additional Resources

Inadequate Media Fills at a Sterile Manufacturer When Starting up After a Shutdown

Sterility Assurance and Cross Contamination

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