FDA inspection

inspection
Manufacturing

FDA unveils 1-day assessment pilot to complement inspections

The new strategy, which seeks to make the FDA's inspection work more targeted and efficient, relies on shorter and more focused screening assessments.
Fraiser Kansteiner May 6, 2026 3:08pm
FDA

FDA clarifies Form 483 expectations after production inspections

May 1, 2026 10:52am
Catalent rebrand Catalent HQ Tampa Florida FL new Catalent HQ headquarters

FDA hit Catalent's Maryland manufacturing sites with Form 483

Dec 19, 2025 11:36am
red light stop light street traffic signal

Alvotech plant issues trigger another FDA biosimilar rejection

Nov 4, 2025 7:40am
FDA

Novo plant issues may mean delays for Regeneron, Scholar Rock

Oct 13, 2025 3:48pm
FDA

J&J subsidiary slapped with FDA warning letter

Sep 23, 2025 2:22pm