How to Prepare for Onsite Facility Inspections

In March 2020, FDA began temporarily postponing all routine domestic and foreign surveillance facility inspections, while continuing mission-critical inspections when possible. This step to restrict site visits during the COVID-19 public health emergency was intended to limit the spread of the virus and maintain a healthy workforce, both for food manufacturers and the FDA. Though mission-critical inspections continued and temporary alternative tools were used to assess many facilities remotely, the pandemic halted many onsite inspections and created a significant backlog for FDA. This means that some facilities have not been visited by an FDA inspector for as many as two years longer than normal.

With COVID vaccinations now available and as the pandemic wanes, the FDA has been working to reestablish onsite inspections and “transition to standard operations,” with FDA inspectors conducting surveillance domestic inspections. They’ve also suggested that some remote tools may continue to be utilized, creating efficiencies for the agency. As a result, it will be important for manufacturers subject to FDA’s oversight to be prepared.

Join AIB International’s Global Manager for Food Defense and Food Safety Modernization Act, Earl Arnold, for guidance on how to achieve success with upcoming onsite inspections. Learn more about the latest developments and how to implement them within your team and facility.

In this webinar, attendees will discover:

How the FDA is prioritizing inspections to address the backlog created by the pandemic.
What may trigger a “for cause” inspection of your facility.
What inspection components may continue to be conducted remotely.
How to prepare your facility and your team for an onsite FDA Inspection.

Amy Montgomery