Snowy Owl
Retired in 2010, In Memoriam
The Wall Street Journal
April 24, 2008, 8:40 am
FDA Uncovers Problems at Merck Vaccine Plant
Posted by Jacob Goldstein
An FDA inspection of Merck?s big vaccine plant in West Point, Pennsylvania found 49 ?areas of concern,? the Philadelphia Inquirer?s Karl Stark reports this morning.
The agency?s report, which the Inquirer got under the Freedom of Information Act, cited issues including unwanted ?fibers? on the stoppers of vials of MMR vaccine and a failure to follow good manufacturing practices.
John T. McCubbins, head of Merck?s Global Vaccine Manufacturing and West Point Operations, pointed out that no contamination was found in finished vaccines and that Merck?s own technicians had detected most of the issues raised in the inspection report. ?We are absolutely confident in the quality of the product,? McCubbins told the Inquirer.
The West Point plant is a major vaccine manufacturing center for Merck, and the report comes as the vaccine business is surging for the company. Merck brought several new vaccines to market in the past few years, driving up sales from $1.1 billion in 2005 to $4.3 billion in 2007, the article says.
URL: http://blogs.wsj.com/health/2008/04...t-merck-vaccine-plant/?mod=WSJBlog/trackback/
April 24, 2008, 8:40 am
FDA Uncovers Problems at Merck Vaccine Plant
Posted by Jacob Goldstein
An FDA inspection of Merck?s big vaccine plant in West Point, Pennsylvania found 49 ?areas of concern,? the Philadelphia Inquirer?s Karl Stark reports this morning.
The agency?s report, which the Inquirer got under the Freedom of Information Act, cited issues including unwanted ?fibers? on the stoppers of vials of MMR vaccine and a failure to follow good manufacturing practices.
John T. McCubbins, head of Merck?s Global Vaccine Manufacturing and West Point Operations, pointed out that no contamination was found in finished vaccines and that Merck?s own technicians had detected most of the issues raised in the inspection report. ?We are absolutely confident in the quality of the product,? McCubbins told the Inquirer.
The West Point plant is a major vaccine manufacturing center for Merck, and the report comes as the vaccine business is surging for the company. Merck brought several new vaccines to market in the past few years, driving up sales from $1.1 billion in 2005 to $4.3 billion in 2007, the article says.
URL: http://blogs.wsj.com/health/2008/04...t-merck-vaccine-plant/?mod=WSJBlog/trackback/