Catalent's Bloomington, IN facility

Catal­ent’s In­di­ana site clos­es out three Form 483s in past two years

One of Catal­ent’s three sites at the cen­ter of the No­vo-Catal­ent deal has been hit by at least three form 483s in the past two years. In the three forms, there were two sep­a­rate men­tions of the site as hav­ing failed to re­view prod­uct batch dis­crep­an­cies, while there were al­so two dif­fer­ent con­cerns on val­i­dat­ing man­u­fac­tur­ing equip­ment.

“Fol­low­ing our com­pre­hen­sive re­sponse and ac­tion plans stem­ming from the No­vem­ber 2023 in­spec­tion, the site has been des­ig­nat­ed by the FDA as VAI,” A Catal­ent spokesper­son told End­points News in an email. The oth­er two 483 forms al­so re­sult­ed in a VAI clas­si­fi­ca­tion from the FDA. A VAI means that the FDA has de­ter­mined the is­sues found do not need fur­ther reg­u­la­to­ry ac­tion.

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