Chi­nese API man­u­fac­tur­er re­ceives FDA warn­ing let­ter af­ter QC em­ploy­ee says test re­sults 'in my mind'

The FDA last week sent a warn­ing let­ter to Chi­na-based Sichuan Dee­bio Phar­ma­ceu­ti­cal af­ter a Sep­tem­ber in­spec­tion led to da­ta in­tegri­ty and oth­er qual­i­ty con­trol ques­tions.

The re­lease of the warn­ing let­ter on Tues­day for the API man­u­fac­tur­er’s site in Xi­aolan Town, Sichuan, fol­lows a clas­si­fi­ca­tion of “of­fi­cial ac­tion in­di­cat­ed” ear­li­er this month, mean­ing the FDA found sig­nif­i­cant is­sues that need to be re­me­di­at­ed.

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