Tag

Form 483

3 stories

Cited Again: Hengrui's 9-Flaw 483 Stalls Liver Drug

Hengrui cleared one FDA citation in six days, only to get hit with a second Form 483, nine observations deep, at a different plant.

FDA Apr 9, 2026

FDA Sets First Formal Rules for Form 483 Responses

FDA issued draft guidance on April 8 giving drug manufacturers their first formal direction on responding to a Form 483, the written list of objectionable…

FDA Apr 7, 2026

FDA Asks Congress for Market Withdrawal Power Over Manufacturing Gaps

FDA's April 3 budget proposal asks Congress for market withdrawal power over postapproval manufacturing gaps and API supplier non-disclosure.