FDA inspection

FDA
Manufacturing

FDA hands warning letters to manufacturers in China, India

A manufacturer of drug ingredients in Tianjin, China has also run afoul of the regulator in a new round of facility writeups.
Fraiser Kansteiner Aug 19, 2026 10:20am
Celcuity

Celcuity needs facility sign-off to kick off its market launch

Aug 18, 2026 9:26am
FDA

2 FDA citations trouble Hengrui, Elevar’s liver cancer combo

Jul 28, 2026 3:02pm
Warning letter

Alembic site hit with warning letter on patient consent concerns

Jul 21, 2026 11:40am
FDA

Novo, Alvotech written up after FDA site inspections

Jul 17, 2026 10:56am
Sanofi

Sanofi unit in Ireland dinged by FDA on Altuviiio production

Jul 1, 2026 2:52pm