RPT-EXCLUSIVE-Lilly hit by staff accusations, FDA scrutiny at COVID drug factories Reuters 3 hrs ago
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By Dan Levine and Marisa Taylor
May 5 (Reuters) - Eli Lilly & Co employees have accused a factory executive of altering documents required by government regulators in an effort to downplay serious quality control problems at the U.S. plant producing the drugmaker’s COVID-19 treatment, according to an internal Lilly complaint and a source familiar with the matter.
The unsigned report, filed April 8 in Lilly’s confidential employee complaint system and reviewed by Reuters, is the latest sign of manufacturing problems at the drug giant. The complaint asserts that the executive, a top quality official at the company’s factory in Branchburg, New Jersey, rewrote findings by Lilly technical experts at the plant, which has been under investigation by the U.S. Food and Drug Administration, to make the conclusions app
Read more about Lilly hit by staff accusations, FDA scrutiny at Covid-19 drug factories on Business Standard. (Reuters) - Eli Lilly & Co employees have accused a factory executive of altering documents required by government regulators in an effort to downplay serious quality control problems at the U.S. plant producing the drugmaker s COVID-19
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(Reuters) - Eli Lilly & Co employees have accused a factory executive of altering documents required by government regulators in an effort to downplay serious quality control problems at the U.S. plant producing the drugmaker s COVID-19 treatment, according to an internal Lilly complaint and a source familiar with the matter.
The unsigned report, filed April 8 in Lilly s confidential employee complaint system and reviewed by Reuters, is the latest sign of manufacturing problems at the drug giant. The complaint asserts that the executive, a top quality official at the company s factory in Branchburg, New Jersey, rewrote findings by Lilly technical experts at the plant, which has been under investigation by the U.S. Food and Drug Administration, to make the conclusions appear more favorable to the company.
Eli Lilly official accused of doctoring documents to downplay serious problems at the plant making the firm s Covid antibody drug
Eli Lilly & Co employees have accused top quality official, Lydia Wible, of altering documents meant to be submitted to the FDA
Staff allege she rewrote findings by Lilly technical experts at a New Jersey plant, to make the conclusions appear more favorable to the company
The documents were about bamlanivimab, which is FDA-approved along with another drug to treat mild-to-moderate cases of COVID-19 in high-risk people
Separately, FDA inspectors found that procedures to ensure certain areas remain sterile at an Indianapolis plant making the drug were substandard