Af­ter 'mis­lead­ing' in­for­ma­tion de­lays FDA in­spec­tion, Chi­nese API man­u­fac­tur­er hit with an OAI

Chi­nese API man­u­fac­tur­er Sichuan Dee­bio Phar­ma­ceu­ti­cal re­ceived an “of­fi­cial ac­tion in­di­cat­ed” clas­si­fi­ca­tion fol­low­ing a Sep­tem­ber Form 483 de­tail­ing qual­i­ty con­trol and batch dis­crep­an­cy is­sues.

The fa­cil­i­ty was flagged by the FDA for poor record keep­ing too, with a team leader telling in­spec­tors that some da­ta re­sults were kept “in her mind.”

The agency not­ed six sig­nif­i­cant ob­ser­va­tions dur­ing its in­spec­tions be­tween Sept. 4 and Sept. 8, 2023 at the site in Xi­aolan Town, Sichuan, in south­east Chi­na. In the Form 483 dat­ed Sept. 8, de­tails of the drug sub­stances af­fect­ed by these is­sues were redact­ed.

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