The U.S. Food and Drug Administration (FDA) has released a new fact sheet introducing the Remote Regulatory Assessments of Animal Food Facilities – Veterinary Feed Directive (VFD) Pilot Study.

This new VFD pilot is similar to the other FDA Remote Regulatory Assessment (RRA) programs for human food and other FDA-regulated products.

The VFD RRA program is completely voluntary and facilities are not required to participate in the program.

What is a Remote Regulatory Assessment (RRA)?

With COVID-19 impacting nearly every aspect of life over the past year, the FDA has developed a remote regulatory assessment (RRA) program to keep FDA, state and facility personnel safe during the pandemic. They hope the RRA program will be useful in the future for increased efficiency, limiting the time an investigator would need to be on-site during an inspection.

The new RRA program will focus solely on Veterinary Feed Directive (VFD) compliance and associated records. 

What is the RRA Pilot Study Process?

The FDA begins by sending a letter requesting voluntary participation in the RRA program. The facility can choose whether or not to participate in the program.

If the facility chooses to participate in the RRA program, they should select one person from the facility to work with the FDA and provide information. The FDA will work with the designated person from the facility to explain the RRA process.

Information requested by the FDA will be shared electronically and securely, and the review process will consist of an FDA review followed by an interview (call or video) between FDA staff and facility staff. The facility can choose to meet with the FDA to provide context about submitted records when they are submitted to the FDA.

After the review process, similar to the traditional inspection process, a facility will send their most responsible person or designee to meet with FDA staff for a close-out meeting. During this meeting, FDA will verbally address any concerns.

What Else Should I Know About the RRA Program?

Since the RRA program is completely voluntary, it is not considered an inspection. As such, the following forms will not be issued as a result of participation in the program:

• FDA 482: Notice of Inspection
• FDA 483: Inspectional Observations

This pilot program will be used to determine whether the FDA can expand the RRA program to other FDA animal food safety regulations.

Read the full FDA fact sheet for more information.

The RRA program isn’t an inspection, but we’re here to help you prepare for inspections. Read our inspection factsheet to learn how to be better prepared before, during and after an inspection.

If you have questions about animal food safety, please contact Marissa Cohen.