NEWS IN BRIEF

FDA resumes domestic inspections as Omicron wave subsides

By Hank Schultz contact

- Last updated on GMT

©Getty Images - Ildo Frazao
©Getty Images - Ildo Frazao

Related tags: regulations

A decline in COVID-19 cases nationwide has led the US Food and Drug Administration to resume domestic surveillance inspections across the country.

The change, which FDA announced on Friday, is set to take effect today.  In December, as part of a response to the rise in COVID-19 cases as a result of the Omicron variant, the Agency had suspended certain inspection activities.

The wave of COVID-19 cases peaked in mid January at more than 300,000 new cases a day.  As of late last week, daily cases numbers were falling rapidly and had declined to about 60,000 new cases a day.

FDA said that while on site inspections will resume, and it continues to conduct both foreign and domestic mission-critical inspections, it will continue to use new tools such as remote assessments. 

The Agency is also proceeding with previously planned foreign surveillance inspections that have received country clearance and are within the Center for Disease Control and Prevention’s Level 1 or Level 2 COVID-19 travel recommendation. The Agency said it plans to start conducting additional foreign inspections starting in April.

Also FDA said it has continued to conduct remote foreign supplier verification program for human and animal foods.

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