FDA Works to Resume On-site Domestic Inspections

July 13, 2020
BioPharm International Editors

The agency is hoping to restart performing on-site domestic inspections during the week of July 20, 2020 depending on factors such as the status of COVID-19 in the state of inspection and local rules and guidelines.

FDA announced on July 10, 2020 that it was planning to restart inspections of domestic facilities the week of July 20, dependent on the trajectory of the virus in the state the facility is located as well as local government rules and guidelines. On-site surveillance inspections of US facilities were put on hold in March 2020 because of the COVID-19 pandemic.

In a statement, FDA Commissioner Stephen M. Hahn, MD said the agency has been monitoring federal, state, and county level reopening criteria to identify where and when domestic facility inspections can resume based on risk factors. FDA has developed a rating system, called COVID-19 Advisory Level, using real-time data to assess the number of COVID-19 cases in an area. The rating system is based on “Phase of the State (as defined by the White House guidelines) and statistics measured at the county level to gauge the current trend and intensity of infection.” FDA will take these factors into consideration to identify regulatory activities that can be performed within a geographic region. Regulatory activities will be grouped into three categories: “mission critical inspections only, all inspections with caveats to help protect staff who have self-identified as being in a vulnerable population, and resumption of all regulatory activities.”

“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. Our ability to resume is also affected by other services that have been curtailed by the pandemic, such as public transportation. The availability of these services will be an important factor in how we determine resuming domestic inspections,” said Hahn in the statement.

Hahn also stated that prioritized domestic inspections will be pre-announced to ensure the safety of both the investigator and the company’s employees. “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,” Hahn said.

Source: FDA