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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.
Additional Resources on Contamination
Inadequate Equipment Cleaning Leads to Cross Contamination, FDA Warnings
FDA on Cross-Contamination, Sustainable Compliance, and Contract Ops
Discolored HEPA Filters Recolored by Sterile Manufacturer
Perforated Tables in Cleanrooms Draw FDA Attention
Prevention of Cross-Contamination in the Pharma Industry
Case Study of Contaminated WFI in China
Cleaning and Cross-contamination Issues with an Encapsulator
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