Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Sanofi Pasteur Vaccine Manufacturing Violations Cited In FDA Warning Letter

This article was originally published in The Pink Sheet Daily

Executive Summary

Sterility issues at the firm's Swiftwater, Pa. manufacturing facility should not impact supplies of the Fluzone influenza vaccine, FDA says.

You may also be interested in...



Sanofi GMP Problems Require Top-level Sit-down With FDA, But Product Impact Limited So Far

Agency’s warning letter also includes an uncommon request for a “global assessment” of operations. FDA says sterility of TheraCys lots manufactured since 2000 cannot be assured; company has halted manufacture of the bladder cancer drug and set limits on orders of its Pentacel vaccine.

HHS Boosts Pandemic Flu Vaccine Stockpile With Contracts Totaling $200 Mil.

Sanofi Pasteur, Novartis and GlaxoSmithKline stand to benefit from government's goal of adding 5.3 mil. doses to national stockpile.

HHS Boosts Pandemic Flu Vaccine Stockpile With Contracts Totaling $200 Mil.

Sanofi Pasteur, Novartis and GlaxoSmithKline stand to benefit from government's goal of adding 5.3 mil. doses to national stockpile.

Related Content

Topics

UsernamePublicRestriction

Register

LL1121650

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel