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Form 483
Manufacturing
FDA scrutinizes Novo on production issues at semaglutide plant
The FDA rebuked Novo Nordisk, the maker of Wegovy and Ozempic, following a March inspection of the company’s production site in Kalundborg, Denmark.
Joseph Keenan
Oct 31, 2024 9:33am
FDA found contamination issues at Thermo Fisher NC plant
Oct 11, 2024 10:42am
Daiichi, Eisai, Granules—Fierce Pharma Asia
Sep 20, 2024 10:16am
Granules receives Form 483 over poor document controls and more
Sep 19, 2024 10:11am
Akeso-Summit, BIOSECURE, Candid and more—Fierce Pharma Asia
Sep 13, 2024 8:53am
FDA issues Form 483s to Japanese, Indian drugmakers
Sep 10, 2024 8:50am
