Form 483

FDA
Manufacturing

FDA clarifies Form 483 expectations after production inspections

The FDA earlier this year unveiled, for the first time, draft guidance on best practices for the industry when replying to the receipt of a Form 483.
Fraiser Kansteiner 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
newspaper

Takeda, Innovent-Lilly, Roche—Fierce Pharma Asia

Oct 31, 2025 8:20am
FDA

FDA scolds Hetero over missteps at India warehouse

Oct 28, 2025 10:00am
FDA

Novo plant issues may mean delays for Regeneron, Scholar Rock

Oct 13, 2025 3:48pm
FDA

Novo plant acquired in Catalent deal lands in FDA's crosshairs

Aug 22, 2025 10:49am