FDA tells Catal­ent to fix is­sues at two man­u­fac­tur­ing sites on its own

The CD­MO Catal­ent will have to fix is­sues at two man­u­fac­tur­ing plants in the US and Eu­rope that were sub­ject to in­spec­tions by the FDA this sum­mer, giv­ing the com­pa­ny room to cor­rect the is­sues with­out fac­ing fur­ther reg­u­la­to­ry ac­tion.

The FDA gave Catal­ent a “vol­un­tary ac­tion in­di­cat­ed” re­sponse to two in­spec­tions at the con­tract man­u­fac­tur­er’s site in Bloom­ing­ton, IN, and Brus­sels, Bel­gium. Fix­ing the is­sues on its own is a prefer­able out­come to fac­ing an “of­fi­cial ac­tion in­di­cat­ed” re­sponse, mean­ing that an of­fi­cial warn­ing would be sent out or a sit-down with the FDA would be re­quired.

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