It has been an interesting two years, to say the least! We have seen unprecedented upheaval in FDA activities from drug approvals to routine inspections and enforcement. It became apparent sometime in mid-2020 that the pandemic was going to be with us for a while and health authorities scrambled to address what this meant for submission review, product approvals, routine inspections, and enforcement.

Both industry and FDA were addressing onsite versus remote work conditions. Both sides were learning on the fly, focused on safety of employees, safety of patients, continuing to push forward the development of investigational products, and maintaining an uninterrupted supply of commercial products.

The data presented here address fiscal years 2020 and 2021, ending Sept. 30, 2021, and trends since FY2013. Drug GMP Warning Letters considered in these metrics were posted by the FDA no later than December 1, 2021. Many Warning Letters were issued for unapproved drug product/adulteration of hand sanitizers but only those which included FDA requests for information were included in this analysis.

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Warning Letters FY2020 and FY2021

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