7/21/2020

Due to the global pandemic, the Food and Drug Administration (FDA) temporarily stopped onsite inspections in March. In the interim, they have been conducting remote assessments following a risk-based approach. The FDA is planning to resume onsite domestic inspections the week of July 20th. During the reopening, the health and safety of all involved will be a priority, and any regional restrictions will be followed.

The FDA will use the “COVID-19 Advisory Rating system” to determine the safety of resuming inspection activities in a certain region. The Advisory Level is based upon:

the phase of reopening in that state, and
county-level statistics on infection levels.

The prioritized inspection sites will be selected based on risk. The Advisory Level will inform what type of inspection activity may be able to be performed at the site. Inspection activities will be categorized into the following:

mission critical inspections,
all inspections with measures to protect those who may be vulnerable, or
normal regulatory activities resume.

The FDA will pre-announce domestic inspections to ensure safety and that any needed staff are able to be present onsite for the inspection. Until the pandemic is resolved, the FDA will continue with the reopening plan.

- The Clinical Pathways Team

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