Author’s Note: Effective February 7, FDA will be resuming domestic surveillance inspections following a pause in onsite inspections due to concerns about the Omicron COVID-19 variant.

What will domestic FDA inspections look like post-COVID? What is FDA’s onsite inspection strategy as the COVID-19 pandemic lingers? What are the best ways to prepare for a records request?

Related: Our free 483 Observation Assessment is a great way to stay on top of FDA enforcement trends. Click here to request your free 483 Observation Assessment.

FDA Office of Regulatory Affairs Assistant Commissioner for Medical Products and Tobacco Operations Elizabeth Miller provided some insights into these questions at the FDLI Enforcement, Litigation, and Compliance Conference in December 2021.

FDA to Evaluate Infection Rates By County Prior Inspection

The agency’s approach to onsite domestic inspections will involve a rating system that examines infection rates in the county where the inspection is to occur, as well as where the investigator resides. This is to ensure the safety of the investigator and personnel at the site.

The rating system is based on three metrics:

Phase of the state as defined by White House guidelines
County level statistics evaluating the rate of infection
County level statistics evaluating the intensity of infections

“By trend, FDA will generally look at the downward trend by day in a county,” Miller said. “A benchmark for FDA to consider for inspection is generally 14 or more days’ downward [in the number of cases] when examining the trend aspect.

“With respect to intensity, FDA will look at generally a two-week timeframe of new cases per 1,000. And the benchmark for FDA is ten or fewer per 1,000 in the county where it would like to inspect.”

These metrics are then used to assign a risk level of either red, yellow, or green. Most FDA inspections will occur at sites assigned a yellow or green risk level. Mission-critical inspections, which include pre-approval inspections, will also be prioritized.

Miller cautioned, however, that sites with a risk level of red also may be inspected if there are concerns.

“If FDA thinks that the public health concern is high enough, the agency will figure out a way to assess the criticality and inspect,” she said.

Preparing for an Onsite Domestic FDA Inspection

At this time, all onsite inspections are preannounced, providing ample time for sites to ensure inspections adhere to state requirements such as temperature checks and face masks.

Other things to consider before the FDA investigator arrives onsite:

Approval may be required to let an FDA investigator onsite
An FDA assessment will need to be completed prior to the inspection
Due to time constraints, FDA likely will issue a records request; these records need to be ready before FDA is onsite
Staff who are working offsite may need to be brought onsite for the inspection
Out-of-state staff may need to quarantine
The front room where FDA investigators will spend most of their time will need to be arranged for social distancing
TV/computer monitors may need to be placed for document reviews

When it comes to the last point, Miller also recommends conducting a “dry run” beforehand.

“Think about how you want to transfer records from the backroom,” she said. “You are going to need to think about how you will exchange records electronically even though the FDA is onsite for the visit.”

FDA also has electronic document limitations. While sites like Box and Dropbox are popular, FDA investigators have limitations when it comes to these sites. This may mean handing over a USB drive with the requested records to the investigator.

Finally, it is critical to have support available during the inspections.

“That applies not only for FDA onsite but if you also have people dialing in remotely. You have to make sure that they have the support they need so you do not have too many delays in that regard,” she explained.

[Author’s Note: For more about preparing for an FDA inspection, watch the following video taken from one of our webinars.]

A Word About Remote FDA Inspections

FDA continues to examine how the agency can conduct remote inspections. But first, some questions will need to be addressed according to Miller.

“Are these going to be assessments? Are these going to be appraisals? Are they going to be something other than what we consider true inspections? Who can participate?”

She then pointed to FDA’s experience with remote audits conducted by Notified Bodies for medical devices.

“Notified Bodies in Europe have been conducting remote inspections throughout the pandemic. And we know that those have started a little bit clunky but have gotten better over time,” she said. “On the FDA side, I will note that the FDA’s MDSAP audits—that is the Medical Device Single Audit Program, which includes Notified Bodies—has been operating under the remote process as well.

“So, FDA does have some of its own experience with remote audits and how they might work in practice.”

Later in her talk, she said, “I think you can do remote inspections as effectively as in-person inspections.”

In her experience with Notified Body audits, there might be two or three, even four, auditors.

This means “you are managing separate workstreams and auditors. You have to staff and basically set up a separate audit for each one of them. You will have to set up front and back rooms and recreate them virtually.”

What About Records Requests?

“You really have to plan ahead as to how you might communicate all the information to the auditor,” she indicated.

Other considerations for records requests include the following:

A strategy for presenting records and also reviewing the records prior to sharing them with the auditor
How to manage multiple time zones if there are multiple auditors
Communicating effectively while remote

When it comes to factory tours, there are concerns about privacy and intellectual property (IP). Miller also conceded that virtual factory tours are one area that is not as effective as in-person. Still, it can be done. [Author’s Note: For more information on virtual tours, read the first and fourth articles listed below.]

“I would be hesitant to allow any recording. It is one thing to be on live video walking through your plant but I think you would have to be really careful and thoughtful about allowing video of the factory tour that can be passed around and shared,” she said. “That would be my primary concern in terms of the overall inspection.”