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

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Ilena Rose - 14 May 2008 19:48 GMT

From Health Lover, Ilena Rosenthal

www.BreastImplantAwareness.org/
http://ilenarose.blogspot.com

Merck Slapped With GMP Warning Letter for Vaccine Operations
The MQN Weekly Bulletin
May 9, 2008 | Vol. 2 No. 19
http://www.fda.gov/foi/warning_letters/s6756c.pdf

Merck Slapped With GMP Warning Letter for Vaccine Operations

Mercks 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 firms 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 firms West
Point, Penn., facility between Nov. 27, 2007, and Jan. 17. The
facility produces most of Mercks 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 Mercks 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
www.fda.gov/foi/warning_letters/s6756c.pdf.

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Citizen Jimserac - 15 May 2008 18:39 GMT

> From Health Lover, Ilena Rosenthal
>
[quoted text clipped - 34 lines]
>
> The warning letter can be accessed atwww.fda.gov/foi/warning_letters/s6756c.pdf.

Ilena I was referred to the "Francis" Report by some folks after
deriding them that vaccination programs were lacking in studies
to prove their efficacy while Homeopathy was in the process
of doing this research for decades now.

Problem is that that report is loaded with statistical errors as well
as the astonishing fact that 44% of the children who had
the full complement of 3 shots, 3 months later showed
NO trace of the antibodies that the vaccine was supposed
to have stimulated. If the rates of polio went down,
it sure wasn't the vaccine doing it, not at those rates.

If you have other examples of fallacies in reports
supposedly supporting or justifying vaccination programs, please post.

Thanks
Citizen Jimserac

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