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# Domestic FDA Inspections Resume
- URL: https://www.fdaweb.com/domestic-fda-inspections-resume/
- Published: 2020-07-13T12:00:00.000Z
- Updated: 2026-09-14T16:20:51.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5147168

FDA says it is planning to begin high-priority domestic inspections (on-site surveillance) for medical products and other regulated products during the week of 7/20\. Resuming 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,” an [agency notice](https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-prepares-resumption-domestic-inspections-new-risk-assessment-system?ref=fdaweb.com) says. “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.”

While FDA’s notice applies to domestic inspections, the agency is continuing its pause on conducting foreign inspections, which have been on hold since March. It says that in lieu of physical inspections, it has been using a number of tools as part of the agency’s risk-based approach to ensuring quality, including remote assessments and import alerts as well as other compliance requirements. “As the Covid-19 pandemic continued, we adjusted our processes and guidance as necessary to maintain the appropriate level of review to ensure the safety of consumer products, including hand sanitizer, diagnostic tests and more,” the notice says.

To determine the appropriateness of geographic inspections, FDA says it has developed a rating system to help determine when and where it is safest to conduct prioritized domestic inspections. “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,” it says. “The Advisory Level is based upon the outcome of three metrics: Phase of the state (as defined by White House guidelines) and statistics measured at the county level to gauge the current trend and intensity of infection. When each of these is taken into consideration, the FDA will identify regulatory activities that can occur within the given geographic region. The three main categories of regulatory activity at the county level will be: 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.”

Going forward, FDA also says that the 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,” it says.