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Steven Lynn - 3 Eli Lilly - 2 Lynn - 2 Maggie Fick - 2 Lilly - 1 Andrew Kelly - 1 Clayton - 1 Jefferies - 1
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U.S Branchburg , New Jersey The U.S Lilly's , New Jersey Indianapolis White Oak , Maryland North America
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FDA - 3 Manufacturing - 3 U.S - 2 Novo Nordisk - 2 U.S . Food - 2 Drug Administration - 2 Thomson - 2 Company - 1

Search resuls for: "Steven Lynn"


5 mentions found


☆ FDA finds new manufacturing lapses at Eli Lilly plant
  + stars: | 2024-01-19 | by ( ) www.cnbc.com   time to read: +4 min
An Eli Lilly and Company pharmaceutical manufacturing plant is pictured in Branchburg, New Jersey, March 5, 2021. U.S. inspectors recently uncovered new manufacturing problems at an Eli Lilly plant that has been under scrutiny by federal investigators, according to government records obtained by Reuters. They included problems in tracking manufacturing process and quality controls, as well as lapses in its calibration of equipment and failure to properly maintain facilities and equipment, the inspection report shows. Yet the Indianapolis-based drugmaker has been cited multiple times for manufacturing problems at its U.S. plants over the last few years, Reuters has reported. Three regulatory experts who reviewed the new inspection report described the most recent lapses as serious.
Persons: Eli Lilly, Lilly, Steven Lynn, Lynn Organizations: Company, U.S, Reuters, The, The U.S . Food, Drug, FDA, U.S . Department of Justice, Justice Department, Manufacturing Locations: Branchburg , New Jersey, The U.S, Lilly's, , New Jersey, U.S, Indianapolis
☆ Exclusive: U.S. FDA found lapses at Novo's main U.S. factory in May 2022 -report
  + stars: | 2023-09-20 | by ( Maggie Fick | ) www.reuters.com   time to read: +4 min
Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. A Form 483 is a type of agency report containing "observations" that FDA inspectors "deem to be objectionable". The FDA did not immediately respond to a request for comment on the report, but usually does not comment on inspections. The report from the May 2022 inspection shows that FDA officials found the factory had failed to include one type of bacteria, abbreviated as B. cepacia, on its list of "objectionable organisms". Analysts at Barclays and Jefferies said in notes this week that, although investors may be concerned by news of potential manufacturing issues, they saw minimal impact on Novo's production of semaglutide.
Persons: Andrew Kelly, Clayton, Jefferies, Steven Lynn, Maggie Fick, Josephine Mason, Mark Potter Organizations: Food and Drug Administration, FDA, REUTERS, Novo Nordisk, Reuters, U.S . Food, Drug Administration, Barclays, Manufacturing, Thomson Locations: White Oak , Maryland, U.S, North America, Clayton , North Carolina
☆ 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
☆ U.S.-Backed Researchers Use AI to Probe for Weaknesses in Drug Supply Chains
  + stars: | 2022-11-30 | by ( Richard Vanderford | ) www.wsj.com   time to read: +6 min
The U.S. Department of Homeland Security has approved research that will use artificial intelligence to delve into drug supply chains and probe for weaknesses, including foreign influence. Any overreliance on foreign inputs in drug supply chains could leave the U.S. open to dire shortages in the event of conflict or natural catastrophe. PREVIEWThe DHS-backed dive into drug supply chains will examine to what extent the supply of drugs might be susceptible to disruption. The new DHS-backed study will try to map out supply chains several layers deep, and potentially uncover previously hidden issues, Mr. Tuchman said. Consultant Steven Lynn says the pandemic opened people’s eyes to issues inherent in far-flung pharmaceutical supply chains.
☆ 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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