FDA to Resume Domestic Inspections

The U.S. Food and Drug Administration (FDA) has announced that it will resume domestic inspections of regulated facilities during the week of July 20, 2020, after pausing in March due to COVID-19. “To arm our investigators with the most reliable and accurate information, the FDA has developed a rating system to assist us in determining when and where it is safest to conduct prioritized domestic inspections,” the agency states. “The COVID-19 Advisory Rating system (COVID-19 Advisory Level) uses real-time data to qualitatively assess the number of COVID-19 cases in a local area based on state and national data. We are also making the Advisory Level data available to our state partners who carry out inspections of FDA-regulated entities on the agency’s behalf under contract.”

The agency also announced that the inspections will be pre-announced. “The FDA has also determined that, for the foreseeable future, prioritized 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.”