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.

What are the latest FDA enforcement trends when it comes to lack of contamination control?

Contamination in manufacturing is an issue of concern in GMP operations. FDA investigators want to see robust processes in place that prevent contamination and cross-contamination. It is also a frequent issue cited in FDA warning letters.

Using the Redica Annual Trend report, we can see the number of 483 observations that fall under the category of “Lack of Contamination Control” for the past seven years in North America under the pharma GMP scope.

In the past seven years, there were 117 FDA 483 observations relating to “Lack of Contamination Control” during Production.

If you are involved in inspection preparation, reviewing this list of 483 observations can be helpful in determining where you need to shore up your contamination and cross-contamination prevention measures.

One area to look is cleaning procedures. An FDA investigator pointed out that multiple companies received warning letters for cleaning issues involving equipment. This is a major concern for sites that produce multiple products on the same equipment.

How Redica Can Help You

With Redica’s actionable intelligence, you can unlock insights that enable you to be better prepared for your next inspection. Our Enforcement Analytics enables you to base your audits and inspection planning activity on the most comprehensive and up-to-date inspection and enforcement trends and how you benchmark to the industry.

Contact us today to learn more about how we can help you stay on top of the latest inspection trends involving contamination and other issues.