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.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER