FDA U.S. inspections resumed

FDA resumes inspections in the U.S. starting 2/7.

According to a RAPS article, the FDA announcedthat it will resume domestic surveillance and testing operations on February 7, 2022 based on a decrease in the number of new COVID-19 cases.
FDA’s Burgess will continue to conduct mission-critical domestic and international inspections and use alternative tools and remote assessments to “conduct effective surveillance of food, drugs, medicines, and tobacco.” He stated.

Last December 29, the FDA suspending many of its inspections to ensure the safety of FDA employees and regulated companies as they further adapt to the evolving COVID-19 pandemic and omicron strain mutation and its spread. The announcement was made. At the time, the FDA said it would suspend all but mission-critical domestic and international inspections until January 19, although it would “reevaluate plans as necessary.
It then reported that it had extended the suspension of inspections until February 4.

Burgess added, “The Department will also continue its previously planned inspections of foreign countries that have been approved by the State and are within the scope of a Centers for Disease Control and Prevention (CDC) Level 1 or Level 2 COVID-19 travel advisory. Plans for additional foreign inspections are underway, and we plan to conduct high-priority inspections in foreign countries beginning in April.” He also stated.
Currently, Japan is at CDC Level 3, so if the status quo remains unchanged after April, FDA inspections will not be conducted except for mission-critical products.

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