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

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

Merck’s 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 firm’s 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 firm’s West
Point, Penn., facility between Nov. 27, 2007, and Jan. 17. The
facility produces most of Merck’s 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 Merck’s 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.