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Top related persons:
Wegovy - 1 Catalent - 1 Eli Lilly - 1 LLY.N - 1 Susan Bain - 1 Karsten Munk Knudsen - 1 Ambre James - 1 Brown - 1
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U.S Brussels Danish University of Southern California Wegovy Novo America United States
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U.S . Food - 1 Drug Administration - 1 FDA - 1 Novo Nordisk - 1 University of Southern - 1 Novo executives - 1 Novo - 1 U.S - 1

Search resuls for: "Susan Bain"


2 mentions found


☆ Insight: Wegovy weight-loss injection factory plagued by sterile-safety failures
  + stars: | 2023-07-27 | by ( Maggie Fick | ) www.reuters.com   time to read: +10 min
Microbial contamination of drugs injected into the body, rather than swallowed, can be deadly, the people said - although the FDA inspectors didn't report any signs of this sort of contamination at the Brussels factory. In both visits, the FDA inspectors found Catalent staff had repeatedly failed to investigate why equipment was malfunctioning. BLINDSIDED BY BOOMING DEMANDWithin months of launching Wegovy, Novo Nordisk was overwhelmed by demand in America, and told shareholders that its initial supply would not keep pace. From December that year and throughout 2022, Novo repeatedly pushed out the timeline for when the supply constraints would end. In late December 2022, Novo announced all five dose strengths were available again in the United States.
Persons: Wegovy, Catalent, Eli Lilly, LLY.N, Susan Bain, Karsten Munk Knudsen, Ambre James, Brown, James, Knudsen didn't, Steven Lynn, Lynn, David Talmage, didn't, Novo, Maggie Fick, Vincent Flasseur, Michele Gershberg Organizations: U.S . Food, Drug Administration, Reuters, FDA, Novo Nordisk, University of Southern, Novo executives, Novo, U.S, Manufacturing, Parenteral Drug Association, Thomson Locations: U.S, Brussels, Danish, University of Southern California, Wegovy, Novo, America, United States
☆ Exclusive: U.S. finds new quality problems at Lilly drug factory
  + stars: | 2022-10-11 | by ( Dan Levine Marisa Taylor | Dan Levine | Marisa Taylor | ) www.reuters.com   time to read: +5 min
The U.S. Food and Drug Administration findings come nearly three years after the agency's inspectors began documenting quality-control issues at the same Lilly plant in Branchburg, New Jersey. FDA inspectors returned to the plant this past July, spending 12 days there. Lilly did not directly respond to questions about the FDA inspectors' findings. The FDA report did not say whether the medicines in question were ultimately shipped to customers or discarded. In November 2019, FDA inspectors found that quality-control data had been deleted and not appropriately audited at the New Jersey plant.
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