FDA sends warn­ing let­ter to com­mu­ni­ty hos­pi­tal re­view board over re­search con­cerns

An in­sti­tu­tion­al re­view board (IRB) for a hos­pi­tal in South Flori­da has been hit with a warn­ing let­ter from the FDA over con­cerns raised dur­ing an in­spec­tion late in 2021.

The let­ter, sent ear­li­er this month to Sima Marzban, the VP of re­search and aca­d­e­m­ic af­fairs for the Larkin Com­mu­ni­ty Hos­pi­tal In­sti­tu­tion­al Re­view Board, states that an in­spec­tion was con­duct­ed in No­vem­ber to see if the hos­pi­tal’s hu­man stud­ies com­plied with FDA re­quire­ments. The site was is­sued a Form ‘483, how­ev­er, in­ves­ti­ga­tors no­ticed af­ter re­view­ing the IRB’s re­sponse that it “did not ad­here to ap­plic­a­ble statu­to­ry re­quire­ments” that gov­ern the pro­tec­tion of hu­man sub­jects.

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