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Preparing for 2022 FDA Inspections

While global travel may be on its way back to normal, routine FDA inspections remain in limbo. What does the future look like for FDA audits and what can companies do to keep up with uncertain times?

The Situation – From March 2020 Until Now

The past 18 or so months have been anything but easy for businesses worldwide. It has been a particularly rocky road for the FDA and companies that depend on regulatory approval to bring their products to market. 

Back in March 2020, due to growing safety risks and global uncertainty, the U.S. Food and Drug Administration (FDA) announced an indefinite halt on most foreign and domestic inspections. Unfortunately, the world didn’t snap back to normal soon after, leaving the FDA and a significant number of life sciences, food manufacturing, and other related companies hanging in limbo. As Summer 2020, approached, the FDA slowly began rolling out limited domestic inspections that were deemed “high-priority” or “mission-critical.” In fact, between March 2020 and October 2020, only three international and 52 domestic inspections fell under this category. Without a viable alternative, a small allowance of high-priority inspections became the norm, and overall, FDA inspections decreased by 56% in 2020 compared to previous years.

That was over one year ago, and to the surprise of many, not much has changed since then. As of summer 2021, the FDA is still prioritizing only high-priority inspections with no concrete plan moving forward. Yet, the pressure is on. Astonishingly, the FDA retains approximately 23,297 total inspections through 2021. Tackling this immense backlog will be no small task. 

The Government Presses the FDA for Answers

Understandably, the government has stepped in to oversee the inspection timeline, putting pressure on the agency to provide a specific plan of action. 

In July 2021, the House Appropriations Committee released its budget for 2022, which includes a $257 million increase in FDA funding, $5 million of which will go specifically to increased FDA inspections, including foreign and unannounced inspections. Other funds will go to drug safety surveillance and oversight and data modernization, which may accelerate the adoption of emerging technology and remote protocols. 

Preparing for 2022 Remote Inspections

While the future is uncertain, the understanding is clear: 2022 FDA inspections will be different. The exact inspection protocol may be murky, but there is no denying the imminent pressure on life sciences, manufacturing, and other companies to ensure preparation and compliance. With an already substantial backlog, a failed inspection could mean significantly longer delays in product development and annual timelines. 

Whether 2022 inspections will be in person, virtual, or unannounced, one clear way companies can prepare is through Virtual Inspection Training enabled by remote presence technology. Through site-specific virtual inspection technology, an FDA expert or regulatory consultant can be “on-site” to prepare global teams before an audit. 

Virtual inspection training serves to align members of teams and organizations well ahead of their virtual, in-person, or announced FDA inspection. Virtual inspections are also a cost-effective method for internal inspections, and many companies have since switched to a remote audit internal protocol during the pandemic. 

How Does Virtual Inspection Technology Differ from Standard Videoconferencing?

In order to get a sense of depth and context of a space, auditors or trainees need the right kind of platform to feel virtually present. The quality of a virtual inspection depends on seeing the finer details and interacting with people on site. During the pandemic, companies across the world replaced meetings with standard videoconferencing platforms, such as Teams or Zoom. Even pharmaceutical and other life sciences companies turned to these tools to conduct internal inspections. 

However, standard videoconferencing was made for faces, not places. A Zoom or Teams POV is restricted to wherever the host points the camera, thereby limiting the freedom and access of view. 

Platforms purpose-built to enable on-site, remote access, such as Avatour, come with a few crucial distinctions from standard videoconferencing: 

  • 360° view: A complete, 360° view provides the full context of a facility or space.
  • Autonomous Viewing: Remote auditors or trainers can choose their own point of view, navigate at their own pace, and interact with on-site employees as if they were physically present.
  • Real-time Collaboration: Avatour enables live document/checklist sharing and automation. This feature is crucial for getting everybody on the same page, whether referencing an Audit Checklist or other important material. 
  • High Resolution & Low Bandwidth Capabilities: When conducting virtual inspection training, it’s important to see in clear detail. Avatour streams in 4K with low bandwidth capabilities where the connection is unstable.
  • Session Recording: To ensure transparency and trust, it’s vital to not only record a session but also to record a session in 360° view in case any moments or details need to be revisited.

The Takeaway

Whether it happens now or next year, the FDA and other regulatory agencies may expand their approach to inspections, creating an opportunity and need for virtual inspections. While companies affected by the FDA and government policies cannot predict or influence the future, they can do their best to prepare for an increase in FDA inspections, both remote and unannounced. 

To learn more about FDA remote inspections, be sure to watch Avatour and RCA’s joint webinar about 2022 Remote Inspections.

View our handy Remote Inspections Checklist for more information on conducting your own virtual inspection.

To view a personalized demonstration of the Avatour platform and learn more about how it could work in your organization, click here

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