FDA shines light on In­di­an man­u­fac­tur­er’s mis­giv­ings at one of its fa­cil­i­ties

Last month, In­di­an drug man­u­fac­tur­er Au­robindo Phar­ma let the na­tion­al stock ex­change know that they once again in­voked the ire of US reg­u­la­tors. Now the ‘Form 483’ shines a light on what ex­act­ly went wrong.

Ac­cord­ing to the form, sev­er­al ob­ser­va­tions were made at Au­robindo’s Unit VII for­mu­la­tion plant in the vil­lage of Polepal­ly, In­dia dur­ing an in­spec­tion in ear­ly May.

In­ves­ti­ga­tors found an un­ex­plained dis­crep­an­cy and a fail­ure of a batch of its com­po­nents to meet any of its spec­i­fi­ca­tions. The FDA found out spec­i­fi­ca­tion (OOS) as­say and dis­so­lu­tion re­sults had led to the re­jec­tions of four tablet batch­es which were iden­ti­fied by a lack of con­trol over com­pres­sion ma­chine set­tings.

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