FDA cites clean­ing, main­te­nance is­sues at Catal­ent fa­cil­i­ty re­spon­si­ble for Re­gen­eron’s drug re­jec­tion

The FDA iden­ti­fied is­sues with main­te­nance and clean­ing at a Catal­ent man­u­fac­tur­ing fa­cil­i­ty re­spon­si­ble for the FDA re­jec­tion of a new ver­sion of Re­gen­eron’s block­buster drug Eylea.

Re­gen­eron an­nounced last month that the FDA didn’t ap­prove an 8 mg ver­sion of Eylea as a re­sult of an on­go­ing re­view of an in­spec­tion that took place at Catal­ent’s fa­cil­i­ty in Bloom­ing­ton, IN.

The FDA’s in­spec­tion re­port was made pub­lic Fri­day af­ter­noon, and it cites three ob­ser­va­tions from the in­spec­tion, which took place be­tween May 4 and May 12 at the Catal­ent fa­cil­i­ty.

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