FDA inspection at India pharma at center of the cisplatin shortage cites multiple quality issues

An FDA in­spec­tion of the In­tas Phar­ma­ceu­ti­cals man­u­fac­tur­ing fa­cil­i­ty in In­dia that pro­duces the can­cer drug cis­platin, now in short sup­ply, found in­stances of ma­nip­u­lat­ed doc­u­ments and clean­ing vi­o­la­tions.

The 483 in­spec­tion re­port was ob­tained by End­points News via a FOIA re­quest. It re­vealed a range of is­sues at the plant in Ahmed­abad, In­dia, in­clud­ing vi­su­al in­spec­tion records that had been al­tered to lessen the risk of a batch in­ves­ti­ga­tion and com­plaints of odors and smells that were nev­er checked out.

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