• FDA to Resume Domestic On-Site Inspections

    The U.S. Food and Drug Administration is aiming to resume on-site inspections of FDA-regulated facilities beginning the week of July 20, the agency announced.

    The FDA had suspended on-site inspections in March amid the COVID-19 pandemic, but agency investigators did conduct “mission critical inspections.” As the pandemic continued, the agency adjusted its processes “to maintain the appropriate level of review to ensure the safety of consumer products, including hand sanitizer, diagnostic tests and more,” the FDA said in a news release issued Friday.

    The agency has also developed a rating system, which it is using to determine when and where it is safe to conduct inspections.

    The advisory level is based on the state’s phase (as determined by White House reopening guidelines, and county-level statistics gauging current COVID-19 trends.

    The week of July 20 is the FDA’s goal to resume inspections, but the agency added that the timing will depend on COVID-19 data in states and localities.

    “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,” the news release says.

    For the foreseeable future, the FDA says it will pre-announce its inspections to FDA-regulated facilities.

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

    One exception to this will be inspections of tobacco retail sellers, as they are undercover operations, the agency said.

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