HomeLatest ThreadsGreatest ThreadsForums & GroupsMy SubscriptionsMy Posts
DU Home » Latest Threads » Forums & Groups » Main » Latest Breaking News (Forum) » Eli Lilly Gets DOJ Subpoe...

Thu May 27, 2021, 07:35 PM

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 drugmaker’s 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 weren’t 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 plant’s 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.

TO READ THE FULL STORY
SUBSCRIBE
SIGN IN
The Wall Street Journal
Continue reading your article with
a WSJ membership

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


2 replies, 1112 views

Reply to this thread

Back to top Alert abuse

Always highlight: 10 newest replies | Replies posted after I mark a forum
Replies to this discussion thread
Arrow 2 replies Author Time Post
Reply Eli Lilly Gets DOJ Subpoena Related to N.J. Plant (Original post)
mahatmakanejeeves May 2021 OP
Maxheader May 2021 #1
dweller May 2021 #2

Response to mahatmakanejeeves (Original post)

Thu May 27, 2021, 07:43 PM

1. Pharmy corps give all kinds of negative..


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..

Reply to this post

Back to top Alert abuse Link here Permalink


Response to mahatmakanejeeves (Original post)

Thu May 27, 2021, 07:48 PM

2. bamlanivimab 🤨

I’ve 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 😐

✌🏻

Reply to this post

Back to top Alert abuse Link here Permalink

Reply to this thread