Sus­pend­ed Cal­i­for­nia cell ther­a­py man­u­fac­tur­ing site hit with FDA warn­ing let­ter over ma­jor qual­i­ty con­cerns

A cell ther­a­py out­fit in Cal­i­for­nia that man­u­fac­tures a hu­man um­bil­i­cal cord de­rived cel­lu­lar prod­uct and ex­o­some prod­ucts is fac­ing a warn­ing from the FDA over sev­er­al ma­jor ob­ser­va­tions re­lat­ed to qual­i­ty.

The FDA notes the site’s “de­fi­cient donor screen­ing prac­tices, in­ad­e­quate asep­tic prac­tices, un­val­i­dat­ed man­u­fac­tur­ing,” and the “risk that your prod­ucts may be con­t­a­m­i­nat­ed with mi­croor­gan­isms or have oth­er se­ri­ous prod­uct qual­i­ty de­fects.”

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Recon Strategy

Boston, MA, USA