FDA warns Take­da over asep­tic pro­cess­ing, in­ad­e­quate in­ves­ti­ga­tions

The FDA last week warned Japan­ese drug­mak­er Take­da over good man­u­fac­tur­ing prac­tice (GMP) vi­o­la­tions ob­served dur­ing an in­spec­tion of its Hikari, Ya­m­aguchi fa­cil­i­ty last No­vem­ber.

Specif­i­cal­ly, the warn­ing let­ter cites the firm for three vi­o­la­tions re­lat­ing to its pro­ce­dures for asep­tic man­u­fac­tur­ing and in­ves­ti­ga­tions in­to un­ex­plained dis­crep­an­cies and equip­ment mal­func­tions.

“Our in­spec­tion found that your Qual­i­ty Unit (QU) did not take ap­pro­pri­ate steps pri­or to re­sump­tion of asep­tic man­u­fac­tur­ing af­ter a shut­down that in­clud­ed mul­ti­ple sig­nif­i­cant ac­tiv­i­ties that com­pro­mised your clean­room con­trol,” FDA writes.

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