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Jan 19, 2024 · U.S. inspectors recently uncovered new manufacturing problems at an Eli Lilly plant that has been under scrutiny by federal investigators, ...
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May 4, 2023 · Lilly has raised manufacturing flags at the FDA multiple times in recent years. Aside from the Indianapolis Form 483 posted this week, the FDA ...
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Aseptic manufacturing concerns have landed Eli Lilly and Rentschler separate Form 483s at facilities that have previously fallen foul of the US FDA.
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Mar 8, 2001 · Response to Observation No.1. We believe that the data made available to the investigators during the inspection.
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Sep 15, 2023 · Eli Lilly and Company - Form 483, 2023-09-15 inspected on September, 2023 Inspected by FDA Investigator: Jennifer A Kemp and 1 others.
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Jan 30, 2024 · Exclusive: Eli Lilly supplied schizophrenia drug to uncertified healthcare providers, Form 483 shows ... 483 obtained by Endpoints News through a ...
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An Eli Lilly facility, which fills COVID-19 antibodies along with other drugs, has received a US FDA Form 483 with seven observations.
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Feb 1, 2024 · Enpoints notes that: “Eli Lilly shipped its schizophrenia drug to uncertified pharmacies and was not adhering to established safety procedures“.
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Aug 12, 2021 · The observations follow a February to March 2021 inspection at the site, which makes several medications: bamlanivimab and etesevimab for COVID- ...
A recall of Lilly's brand of immediate action and enteric coated prescription thyroid tablets was initiated by the firm June 22 based on stability studies ...
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