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Form 483
Pharma
Novo, Alvotech written up after FDA site inspections
From Indiana to Iceland, the FDA disclosed concerns raised during recent visits to a pair of manufacturing sites with troubled regulatory histories.
Fraiser Kansteiner
Jul 17, 2026 10:56am
Huahai poaches quality chief from Hengrui amid FDA citations
Jul 16, 2026 4:11pm
FDA issues Form 483 to Dr. Reddy's plant in India
Jun 26, 2026 11:40am
FDA clarifies Form 483 expectations after production inspections
May 1, 2026 10:52am
FDA hit Catalent's Maryland manufacturing sites with Form 483
Dec 19, 2025 11:36am
Takeda, Innovent-Lilly, Roche—Fierce Pharma Asia
Oct 31, 2025 8:20am
