FDA says it will conduct less than half of the drug, device inspections it planned for 2021

Katie Adams -

Citing restrictions related to the pandemic, the FDA will perform less than half of the non-food domestic surveillance inspections it had planned for fiscal year 2021, the agency said May 5.

The FDA said that as of March, 3,229 non-food domestic inspections still needed to be conducted before Sept. 30, when fiscal year 2021 ends. It said it is unsure how many of those inspections it will be able to perform, as uncertainties about travel restrictions remain.

The agency said if it returns to standard inspection procedures by mid-summer, it will conduct just 851 non-food domestic inspections, 26 percent of the non-food domestic inspections remaining for fiscal year 2021.

FDA Deputy Commissioner for Food Policy and Response Frank Yiannas told Politico the agency is uncertain when its domestic inspection operations will fully return to normal, as it "depends on what happens with the pandemic, the virus and whether variants emerge."

 

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