Form 483 un­masks man­u­fac­tur­ing is­sues at Alvotech be­fore its CRL, and one for Au­robindo too

Ear­li­er this month, the Ice­landic biotech Alvotech re­ceived a re­sponse let­ter from FDA sur­round­ing its po­ten­tial in­ter­change­able biosim­i­lar to Ab­b­Vie’s Hu­mi­ra, which dis­cussed sev­er­al de­fi­cien­cies at a Reyk­javik fa­cil­i­ty.

On Tues­day, the FDA un­veiled the 483 for that fa­cil­i­ty, find­ing sev­er­al is­sues re­lat­ed to pro­ce­dur­al and qual­i­ty con­trol, among 13 ob­ser­va­tions.

The FDA found that Alvotech’s fa­cil­i­ty, in­spect­ed in March, lacked the pro­ce­dur­al con­trols to en­sure that in­com­ing ma­te­ri­als were prop­er­ly qual­i­fied, as an in­ter­nal in­ves­ti­ga­tion in­to the fa­cil­i­ty’s de­vi­a­tion man­age­ment sys­tem was not con­duct­ed.

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