Pharmaceutical Processing World

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

FDA Says All of Chiron’s Liverpool Flu Vaccine Output Is Unsafe

By Pharmaceutical Processing | October 19, 2004

WASHINGTON, DC (October 18, 2004) – The Food & Drug Administration (FDA) said Friday that none of the influenza vaccine manufactured by Britain’s Chiron Corp. for the US market is safe for use.

The FDA said it based its determination on the agency’s evaluation and inspection of Chiron’s influenza vaccine manufacturing plant in Liverpool, England.

The purpose of the FDA inspection was both to evaluate Chiron’s investigation, testing and assessment of the defects detected in nine of the 100 lots of their finished flu vaccine (Fluvirin) manufactured for this year’s flu season and also to evaluate their determination that the risk of defects was confined to those specific lots.

The FDA said the safety of the vaccine supply is of the “highest priority to FDA and the Department of Health & Human Services.” The FDA said it has provided Chiron with the agency’s inspectional observations and has met with the company to evaluate theirresponse and assure that the necessary corrective actions are taken.

The agency said it planned to work with Chiron and the British government to correct the deficiencies in the plant. The quarantined lots of Chiron vaccine already in the United States are undergoing further evaluation, the FDA said.

Meanwhile, the Department of Health & Human Services said it will “continue to exhaust every avenue” to secure more flu vaccine for this season. The department said it is contacting “literally every known manufacturer of flu vaccine in the world” and that some progress is being made.

Related Articles Read More >

Wyzo
Wyzo high-speed pick-and-place sidebot wins design awards
Purdue University
Purdue University launches institute for advanced manufacturing of pharmaceuticals
Sanofi logo
Sanofi introduces its first digital accelerator 
Cambridge Pharma launches with UK plant in Cambridge Research Park

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