A Parenting & kids forum. ParentingBanter.com

If this is your first visit, be sure to check out the FAQ by clicking the link above. You may have to register before you can post: click the register link above to proceed. To start viewing messages, select the forum that you want to visit from the selection below.

Go Back   Home » ParentingBanter.com forum » misc.kids » Kids Health
Site Map Home Authors List Search Today's Posts Mark Forums Read Web Partners

Merck Slapped With Warning Letter for Vaccine Operations ... Drugs used for Vaccines Adulterated

Thread Tools Display Modes
Old May 14th 08, 07:48 PM posted to misc.health.alternative,talk.politics.medicine,misc.kids.health,talk.politics.medicine
Ilena Rose
external usenet poster
Posts: 1,139
Default Merck Slapped With Warning Letter for Vaccine Operations ... Drugs used for Vaccines Adulterated

From Health Lover, Ilena Rosenthal


Merck Slapped With GMP Warning Letter for Vaccine Operations
The MQN Weekly Bulletin
May 9, 2008 | Vol. 2 No. 19

Merck Slapped With GMP Warning Letter for Vaccine Operations

Merckís bulk drug substances used to manufacture many of its vaccines
are adulterated, and the FDA is requesting a meeting with senior
management to expedite the firmís corrective actions, according to a
recent warning letter.

The FDA cited the company for numerous GMP violations at its vaccine
production operations, including those for human papillomavirus
vaccine Gardasil and combination measles, mumps, rubella and chicken
pox vaccine ProQuad.

The warning letter resulted from an inspection at the firmís West
Point, Penn., facility between Nov. 27, 2007, and Jan. 17. The
facility produces most of Merckís vaccines, the company said. The
inspection resulted in 49 Form 483 observations.

In a question-and-answer statement, the FDA said the deviations do not
affect the safety of Merck vaccines, and no shortages are expected.

Merck has been plagued with manufacturing problems for its vaccines
containing varicella. Potency issues for bulk varicella have created
supply disruptions for Zostavax and ProQuad, which is not available
for purchase.

During Merckís first quarter earnings call, CEO Richard Clark said the
FDA is reviewing regulatory submissions for a new varicella
manufacturing process.

The warning letter can be accessed at

Thread Tools
Display Modes

Posting Rules
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

vB code is On
Smilies are On
[IMG] code is On
HTML code is Off
Forum Jump

Similar Threads
Thread Thread Starter Forum Replies Last Post
SCIENTIST: How Much Should Gardasil Cost? Merck could cut the price of its new vaccine by 90% and still do very well. Ilena Rose Kids Health 0 August 28th 07 01:49 AM
Bowel problem seen in infants given Merck vaccine [email protected] Kids Health 5 February 14th 07 05:49 PM
Deadly side-effects earn ADHD drugs warning Ilena Rose Kids Health 31 June 2nd 06 02:10 PM
Two Eczema Drugs Should Have Cancer Warning -- FDA Roman Bystrianyk Kids Health 0 March 11th 05 02:56 PM

All times are GMT +1. The time now is 06:02 AM.

Powered by vBulletin® Version 3.6.4
Copyright ©2000 - 2019, Jelsoft Enterprises Ltd.
Copyright ©2004-2019 ParentingBanter.com.
The comments are property of their posters.