FDA To Use COVID-19 Risk Assessment System As It Restarts Domestic Inspections; Most Will Be Preannounced

Goal Is To Resume During the Week of July 20; Disease Threat in Each Location Will Be Critical
Dennis Tosh
July 10, 2020 at 02:50 PM EST
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As it moves to resume prioritized domestic on-site surveillance inspections, the FDA announced July 10 that it plans to use a COVID-19 risk rating system to help the agency determine when and where it is safe to inspect the facilities of FDA-regulated companies.

The agency’s goal is to restart in-person inspections during the week of July 20.

How the System Works

Commissioner of Food and Drugs Dr. Stephen M. Hahn said that the agency’s COVID-19 Advisory Rating System (COVID-19 Advisory Level) “uses real-time data to qualitatively assess the number of COVID-19 cases in a local area based on state and national data.”

The COVID-19 Advisory Level for a particular locality will be derived from the phase of the state as defined by the White House Guidelines for Opening Up America Again and from available county-level statistics gauging the locality’s current disease trend and the intensity of its COVID-19 infection.

Using these data, the FDA will determine the regulatory activities that can occur within a geographic region. The main categories of activities from which the agency will choose are:

  • conducting mission-critical inspections only;
  • conducting all inspections, with measures in place to help protect FDA staff who have self-identified as being in a population that is vulnerable to COVID-19; and
  • resuming all regulatory activities.

Factors Affecting Restart Date

Meeting the goal of restarting inspections the week of July 20 “will depend on the data about the virus’s trajectory in a given state and locality, and rules and guidelines that are put in place by state and local governments,” Hahn said.

“In order to move to the next phase, we must see downward trends in new cases of COVID-19 and hospitalizations in a given area,” he added. “Our ability to resume is also affected by other services that have been curtailed by the pandemic, such as public transportation.”

Preannouncements ‘For the Foreseeable Future’

Hahn also said that “for the foreseeable future” most prioritized domestic inspections conducted by FDA investigators will be preannounced.

“This will help assure the safety of the investigator and the firm’s employees,” he said, thereby “providing the safest possible environment to accomplish our regulatory activities, while also assuring the appropriate staff are on-site to assist FDA staff with inspection activities.”

An exception will be retail tobacco inspections, Hahn said, which will not be preannounced “as they are undercover operations where the retailer is unaware an inspection is taking place.”

As domestic inspections resume, FDA investigators will be outfitted in personal protective equipment “and equipped with other necessary equipment to carry out their work while adhering to state and local guidance as well as applicable [Centers for Disease Control and Prevention (CDC)] guidance,” he noted.

Hahn said that the White House guidelines and the CDC’s guidance for protecting against workplace exposure to COVID-19 have provided the roadmap by which the agency has been “optimizing operations and new work arrangements.”

Hahn Touts Enforcement Success During Postponement

Since the pandemic began, Hahn said, the agency has conducted “mission-critical inspections and other activities” and has had “great success by using a number of tools as part of the agency’s risk-based approach to ensuring quality.” These tools have included remote assessments, Import Alerts, and other requirements.

At least one Warning Letter — one issued June 22 to H & C Food Inc., Brooklyn, N.Y., for alleged violations of the agency’s Foreign Supplier Verification Program (FSVP) requirements for imported food products — has been based at least in part on a remote inspection conducted by FDA investigators.

Hahn also said that the FDA has adjusted its processes and guidance “to maintain the appropriate level of review to ensure the safety of consumer products,” including hand sanitizers and diagnostic tests.

The FDA announced March 10 that it would postpone most non-U.S. establishment inspections due to the COVID-19 pandemic. Most domestic inspections were postponed on March 18.

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