FDA+ roundup: Num­ber of drug sur­veil­lance in­spec­tions tripled from 2021 to 2022

Back in May 2020, thanks to the Covid pan­dem­ic, the FDA had to press pause on do­mes­tic and for­eign rou­tine sur­veil­lance in­spec­tions, which piled up in­to a back­log of near­ly 8,000 in­spec­tions.

Since then, how­ev­er, the agency now makes clear in a new qual­i­ty re­port that its num­ber of sur­veil­lance in­spec­tions tripled in the last year, from 115 in­spec­tions in 2021 to 328 sur­veil­lance in­spec­tions in 2022. Some of that progress is thanks to agree­ments that the agency has with oth­er coun­tries, as it says 129 in­spec­tion clas­si­fi­ca­tions were due to Mu­tu­al Recog­ni­tion Agree­ments with for­eign reg­u­la­tors, and 49 were sur­veil­lance sys­tems-based as­sess­ments us­ing in­for­ma­tion from FDA re­quests.

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