FDA Prepares to Resume Domestic Inspections

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Silver Spring, MD—FDA is preparing to resume domestic inspections, according to a statement from Stephen M. Hahn, M.D., Commissioner of FDA. The agency is currently looking to restart on-site inspections the week of July 20, but notes that this will depend on the virus’ trajectory in a given state and locality and the rules put in place by state and local governments. “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,” Dr. Hahn wrote.

FDA has made use of The White House Guidelines for Opening Up America Again as a roadmap to help the agency optimize operations and new work arrangements, along with CDC guidance for preventing workplace exposure to COVID, according to the statement.

Over the past few months, FDA has used remote assessments and import alerts to maintain oversight. “At the same time,” Dr. Hahn writes, “we have been closely monitoring reopening criteria established at the federal, state, or county levels and planning to identify when and where to resume domestic inspections, prioritizing the inspections based on risk and other factors.”

FDA has developed the COVID-19 Advisory Rating system, which uses real-time data to qualitatively assess the number of COVID-19 cases in a local area. The Advisory Level is based on the phase of the State as defined by White House guidelines and statistics measured at the county level to gauge the trend and intensity of infection. After taking these factors into account, FDA will identify regulatory activities that can occur within the given region. The three categories of regulatory activity will be: mission critical inspections only, all inspections with caveats to protect staff in a vulnerable population, and resumption of all regulatory activities. FDA is making the Advisory Level data available to state partners who carry out inspections of FDA-regulated entities on the agency’s behalf.

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For the foreseeable future, the statement notes, domestic inspections will be pre-announced to FDA-regulated businesses. “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,” Dr. Hahn explains. He notes that retail tobacco inspections will not be pre-announced, as they are undercover operations.

Dr. Hahn concludes: “The health, safety and well-being of our investigators, as well as the public, are of the utmost importance to us. We will ensure our investigators are outfitted with personal protective equipment and are equipped with other necessary equipment to carry out their work while adhering to state and local guidance as well as applicable CDC guidance. We will continue to work to ensure our prioritized domestic inspections resume appropriately and as safely as possible.”

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