Warning Letters

Manufacturing

FDA cites yet another Lupin plant after preapproval inspection

In a regulatory filing, Lupin said it has received a Form 483 notice from the FDA citing problems at its injectables facility in Nagpur.
Kevin Dunleavy Nov 16, 2022 3:33pm

BMS unit in hot water with FDA over Abraxane production flubs

Nov 9, 2022 12:02pm

In so many words, FDA admonishes drug manufacturer Nephron

Oct 27, 2022 10:13am

Catalent’s Belgium operations get a second FDA scolding

Oct 25, 2022 10:47am

Torrent Pharma hit with FDA Form 483, citing 3 observations

Oct 20, 2022 10:09am

FDA rejects Alvotech's Humira copycat on manufacturing issues

Sep 8, 2022 9:25am