FDA to Resume Routine Inspections
Late last week, the U.S. Food and Drug Administration (FDA) published Coronavirus (COVID-19) Update: FDA prepares for resumption of domestic inspections with new risk assessment system. With this statement, the FDA announced plans to move forward with routine inspections later this month (July 20).
The FDA paused routine on-site inspections in the U.S. in March 2020 in response to the COVID-19 pandemic. Inspectors continued for-cause inspections deemed mission critical by using tools such as remote assessments and import alerts.
The FDA will use a COVID-19 Advisory Rating System to assess the number of COVID-19 cases in areas based on state and national data. This system will be shared with state regulators.
The system uses three (3) metrics to set the FDA’s agenda: the phase of the state, statistics at the county level and intensity of infection. Based on this data, the FDA will determine the most appropriate types of regulatory activities.
The three (3) types of inspections that could occur in a state or area based on the results of the COVID-19 Advisory Rating System are
- mission critical inspections only,
- all inspections with ways to help protect staff who have self-identified as being in a vulnerable population or
- all regulatory activities.
Another important announcement explains that domestic inspections will be pre-announced for the foreseeable future to FDA-regulated businesses.
A good business practice is for facilities to have a robust visitor policy. Businesses should also communicate the details of this policy to investigators as inspections are announced.
Review our fact sheet to learn about ways your facility can use CGMP to reduce the spread of COVID-19.
Need help preparing for inspections? Review our newest factsheet with tips to help you prepare.
If you have questions about FDA inspections, please contact Marissa Herchler.