Phar­ma man­u­fac­tur­ers in In­dia, US lat­est to re­ceive qual­i­ty con­trol hits from the FDA

Two drug man­u­fac­tur­ers on op­po­site sides of the globe are fac­ing the heat from the FDA over sev­er­al qual­i­ty con­trol is­sues.

In­dia-based man­u­fac­tur­er Sun Phar­ma was hit with a Form 483 fol­low­ing an FDA in­spec­tion of its Mo­hali fa­cil­i­ty from Aug. 3-12.

The FDA found fail­ures when re­view­ing un­ex­plained dis­crep­an­cies re­gard­ing whether a batch al­ready had been dis­trib­uted at the lo­ca­tion.

The in­ves­ti­ga­tion found that there were in­stances of back­dat­ing, but Sun’s re­port was not thor­ough enough for the FDA to eval­u­ate the full scope of the of­fense. Sun did not in­ter­view all qual­i­ty as­sur­ance re­view­ers, but it did con­firm back­dat­ing by em­ploy­ees who had de­nied the prac­tice ini­tial­ly. Sun al­so did not have a thor­ough re­view of oth­er work per­formed by the em­ploy­ees, ac­cord­ing to the FDA re­port.

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