The FDA is ramping up its inspections of medical device manufacturing facilities. Are you ready? Since March 2020, the agency has focused on mission-critical inspections due to the COVID-19 pandemic. However, as Omicron cases decline, the FDA is expected to transition back to its regular inspection schedule, and it has a significant backlog to address.
As the FDA resumes its standard operations, it’s important to understand that “normal operations” do not equate to pre-pandemic inspection methods. During the pandemic, the FDA developed novel approaches to conducting inspections, including remote record reviews and other virtual activities. These methods have proven effective and will likely continue to be used, even post-pandemic.
Manufacturers need to be prepared for this hybrid approach to inspections, which combines traditional on-site visits with remote and virtual activities. This shift requires a thorough understanding of both the new and established inspection protocols to ensure compliance and readiness.
By understanding and adapting to the FDA’s evolving inspection methods, medical device manufacturers can ensure they are fully prepared for the increased inspection activity. This proactive approach will help maintain compliance, minimize disruptions, and support continuous improvement in quality management.