Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • R&D 100 Awards

DoJ subpoenas Eli Lilly over bamlanivimab plant

By Brian Buntz | May 27, 2021

Eli LillyIn an SEC filing, Eli Lilly (NYSE:LLY.N) revealed that it had received a subpoena from the U.S. Department of Justice connected to a manufacturing site in New Jersey that produces bamlanivimab, one of two COVID-19 monoclonal antibodies it produces. The plant also produces the blockbuster Trulicity and cancer drugs.

Lilly did not state which types of documents the federal government had requested but noted that it is cooperating with the criminal probe. The U.S. government has not made any specific accusations against Lilly.

According to a Reuters report, Lilly employees had accused an executive of modifying federal documents to cover up quality control problems at the facility in Branchburg, New Jersey.

FDA officials inspected the plant in November 2019 and reported discovering missing data related to various manufacturing processes. The agency concluded that the facility had two counts of inadequate “control of computer systems.”

The FDA used its “Official Action Indicated” designation to refer to the quality control problems at the Branchburg plant. That designation means the agency will recommend “regulatory and/or administrative actions.” If not resolved, the designation can lead the FDA to block the sale of drugs from the facility.

After the FDA inspection, Lilly noted that it had moved to swiftly resolve the problems. The company also stated that it prioritizes the safety and quality of its products.

The company has also said that none of the issues FDA found related to the quality of its commercialized products.

Lilly said it had hired external counsel to oversee an independent investigation of the Branchburg operations.

Earlier this year, Reuters reported that a Lilly human resources employee claimed she lost her job at the Branchburg factory after launching an internal investigation of employee complaints about manufacturing problems, missing records and staff shortages.

The company has denied any retaliation against employees.

 

Tell Us What You Think! Cancel reply

Related Articles Read More >

Pfizer logo
Pfizer and BioNTech seek EMA authorization for COVID-19 vaccination in young children
Pfizer logo
FDA allows pharmacists to prescribe Paxlovid 
vaccine
Will COVID-19 vaccines be updated by fall? 
COVID-19 vaccine
Young children in U.S. now eligible for COVID-19 vaccination

DeviceTalks Tuesdays

DeviceTalks Tuesdays

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Need Pharmaceutical Processing news in a minute?

We Deliver!
Pharmaceutical Processing Enewsletters get you caught up on all the mission critical news you need. Sign up today.
Enews Signup
Pharmaceutical Processing World
  • Subscribe to Our Free E-Newsletter
  • Contact Us
  • About Us
  • Advertise With Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index

Copyright © 2022 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • R&D 100 Awards