Eli Lilly Gets DOJ Subpoena Related to N.J. Plant
Source: The Wall Street Journal.
BUSINESS HEALTH CARE HEALTH
Eli Lilly Gets DOJ Subpoena Related to N.J. Plant
Company says it is cooperating with the probe of issues at the site, which has been flagged for deficiencies after FDA inspections
By Colin Kellaher
May 27, 2021 3:45 pm ET
Eli Lilly & Co. on Thursday said it received a subpoena from the Justice Department seeking documents related to the drugmakers manufacturing plant in Branchburg, N.J.
The Indianapolis company said it is fully cooperating with the investigation of issues at the plant, which has been flagged for deficiencies after inspections by the U.S. Food and Drug Administration and is the subject of employee allegations of document tampering.
The FDA in November 2019 notified Eli Lilly that during an inspection of the plant, where the company makes the blockbuster diabetes drug Trulicity and its Covid-19 antibody drug bamlanivimab, it had found that appropriate controls werent exercised over computers or related production and laboratory systems.
In a report on a subsequent inspection last year, the FDA noted a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. The agency also noted that the plants laboratory controls do not include the establishment of scientifically sound and appropriate lest procedures designed to assure that drug substances conform to appropriate standards of identity, strength, quality and purity.
After each inspection, Eli Lilly told the FDA that it would take corrective actions at the plant.
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Read more: https://www.wsj.com/articles/eli-lilly-gets-doj-subpoena-related-to-n-j-plant-11622144731
Eli Lilly said it is cooperating with a Justice Department probe of issues at its manufacturing plant in Branchburg, N.J., which has been flagged for deficiencies after FDA inspections and is the subject of employee allegations of document tampering
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Maxheader
(4,366 posts)statements when you google pharmacies outside the usofa...
https://www.bing.com/search?q=pharmacys+outside+the+usa&form=CHRDEF&sp=-1&pq=&sc=0-0&qs=n&sk=&cvid=FFB41D245EC3437CBDB44A67D850B6FC
pick on international pharmacy and see the warning..from the board of the nabp
So now it seems there are safety issues in this country..
dweller
(23,562 posts)Ive often wondered how they came up with the names of drugs ... then gave up
This one is just as weird backwards as it is frontwards
bamlanivimab ... bamivinalmab 😐
✌🏻