FDA To Restart On-Site Inspections Paused For Virus

By Kevin Stawicki
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Law360 (July 10, 2020, 7:48 PM EDT) -- The U.S. Food and Drug Administration said Friday it will restart on-site, preannounced domestic inspections, paused in March due to the coronavirus pandemic, equipped with a new rating system for investigators to determine the safest areas to continue the agency's enforcement efforts.

In accordance with the White House Guidelines for Opening Up America Again, the agency said it will send out investigators for on-site inspections by the week of July 20, based on the so-called COVID-19 Advisory Rating system that uses state and national data about infection rates to determine in which regions enforcement can resume.

The advisory level determined by the rating system, which will be available to the FDA's state partners, will be used by the agency to determine whether inspections should be "mission critical," limited in scope considering risk of infection or fully back to normal operations, the agency said.

Inspections will be based on declining trends in new COVID-19 cases and hospitalizations, state and local guidelines, as well as the availability of transportation and other services, the agency said. Most inspections for FDA-regulated companies will also be preannounced, with the exception of retail tobacco companies, the agency added.

After suspending domestic and foreign inspections on March 10 due to the pandemic, the FDA nonetheless continued a variety of enforcement activities such as issuing advisories and warning letters.

In March, the FDA cautioned consumers to avoid nine hand sanitizer products manufactured in Mexico that may contain methanol, or wood alcohol, which could be toxic if absorbed through the skin or ingested.

The agency also took steps to boost the production of hand sanitizers, which have flown off store shelves during the pandemic, and issued a final rule seeking more data on the effectiveness and safety of three active ingredients found in over-the-counter hand sanitizers.

For months, the agency has been sending out handfuls of warning letters to companies hawking products, including CBD products and oral peroxide gel, with unproven claims that they can treat or prevent COVID-19. According to the agency, it has sent warning letters over COVID-19 to 250 companies and people since the pandemic started.

Then on June 16, the FDA announced it had revoked the emergency use authorization for the COVID-19 antibody test of Chembio Diagnostics Inc., a point-of-care diagnostics company, due to "performance concerns with the accuracy of the test."

A representative for the FDA did not immediately respond to a request for comment Friday.

--Additional reporting by Emily Field, Dean Seal and Hailey Konnath. Editing by Stephen Berg.

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