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.

I’m comparing the enforcement histories of two CMOs’ sites over a ten-year period. How can I quickly and easily find this information?

At Redica, we recognize that ensuring quality and compliance at contract manufacturing organization (CMO) sites is critical (and an FDA expectation to boot!). Our Benchmark Report allows you to quickly compare the enforcement histories for a set of sites of your choosing.

For an example of how the Benchmark report works, let us go into Redica. Here we can visit the sites within a company’s network and select the ones that interest us into a group. In this case, select a handful of the company’s sites in North America and Europe for each. Then, repeat for a different company. Both companies are leading CMOs in the pharmaceutical GMP space.

Next, create a Benchmark Report filtered by the previous ten years (2012-2021) and human drugs GMP.

Now the data shows a set of sites from the first company has been inspected at twice the rate of the other firm. It also has more 483 observations and two CFR citations. You can also dive into the individual observations of the Benchmark Report.

If you were in the process of choosing between two CMOs, this kind of information would be valuable and likely factor into your decision-making. The Benchmark Report also allows you to compare enforcement histories for sites within a single company. CMOs often have a network of manufacturing sites. Perhaps some have better enforcement histories than others.

How Redica Helps With Vendor Quality

With more than 300,000 unique Site Profiles across GLP, GCP, GDP, and GMP vendors, you will never be in the dark about your vendors’ regulatory history and their most up-to-date inspection information. Our models show what the FDA is looking for, and the deficiencies it finds—not just at a high level of detail, but at an actionable level of detail.

In fact, customers have often told us that they were unaware a vendor or CMO they partner with received a negative enforcement action, such as a 483 observation. Remember, no matter where product is manufactured, it is still the responsibility of the company to ensure product quality.