Pharmaceutical & Life Sciences News

On-Site Drug, Food Inspections to Resume After March Pause

July 10, 2020, 3:44 PM

The FDA plans to resume on-site inspections of domestic drug and food facilities the week of July 20 after halting most inspections in March, the agency said Friday.

Agency officials will use a new rating system that analyzes the rate and severity of Covid-19 cases in an area to decide where it’s safest to conduct inspections.

“Resuming prioritized domestic inspections will depend on the data about the virus’ trajectory in a given state and locality and the rules and guidelines that are put in place by state and local governments,” Food and Drug Administration Commissioner Stephen Hahn said in a statement.

“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 said.

Most inspections will be announced beforehand to ensure the safety of the staff. Retail tobacco inspections won’t be announced beforehand because those are typically undercover operations, according to an FDA statement.

To contact the reporter on this story: Jacquie Lee in Washington at jlee1@bloomberglaw.com

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloomberglaw.com; Alexis Kramer at akramer@bloomberglaw.com

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