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Regulatory Focus™ > News Articles > 2020 > 5 > FDA plans phased approach to restarting surveillance inspections

FDA plans phased approach to restarting surveillance inspections

Posted 12 May 2020 | By Michael Mezher 

FDA plans phased approach to restarting surveillance inspections

After halting most foreign and domestic inspections in March due to the coronavirus disease (COVID-19) outbreak, the US Food and Drug Administration on Monday said it is working with the Centers for Disease Control and Prevention (CDC) on a phased plan for resuming on-site surveillance inspections.
In March, FDA said it would halt foreign inspections and domestic routine surveillance inspections and would only conduct “mission-critical” foreign or domestic for-cause inspections. In lieu of on-site inspections, the agency said it would resort to alternative means of oversight, such as evaluating records from facilities. (RELATED: Coronavirus prompts FDA to cancel travel, postpone inspections and meetings, Regulatory Focus 10 March 2020; FDA halts domestic surveillance inspections, Regulatory Focus 18 March 2020).
FDA had previously limited travel and inspections in China in February while the COVID-19 outbreak was mostly centered in the country.
Now, FDA says it will continue to rely on “alternative inspection tools and approaches” as it postpones most routine surveillance inspections. “This will continue as local, national and international conditions warrant,” said FDA Commissioner Stephen Hahn.
Hahn also said the agency is working with the CDC to formulate a process for “how and where” to begin those inspections in the future in line with White House guidelines to ensure inspections are carried out safely.
“We expect this to be a phased approach driven by scientific data. Our priority and commitment are to first protect the health and well-being of not only our own highly-skilled workforce and state contract inspectors, but also the health of workers in the important industries we regulate,” Hahn said.

Tags: coronavirus, US

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