Com­mon can­cer drug man­u­fac­tur­er warned by the FDA over da­ta in In­dia

Wracked with qual­i­ty ques­tion marks that have caused ma­jor short­ages of com­mon can­cer drugs, In­dia-based gener­ic drug man­u­fac­tur­er In­tas Phar­ma­ceu­ti­cals has been hand­ed a warn­ing let­ter from the FDA over sev­er­al da­ta is­sues, in­clud­ing shred­ded and de­stroyed doc­u­ments.

In­spec­tors at In­tas’ site in Sanand, In­dia saw mul­ti­ple in­frac­tions, ac­cord­ing to the ini­tial 36-page in­spec­tion re­port, that were fur­ther spelled out in a warn­ing let­ter is­sued to In­tas last Fri­day.

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